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USA/Europe Med Device Regulatory 2023 News/Updates recap

February 5, 2024 | Medical Device

BELGIUM

Federal Agency for medicines and health products (FAMHP) has released a notice on Deadlines for the submission of dossiers during the end-of-year period

During the end-of-year period, the FAMHP will be closed from Monday 25 December 2023 to Monday 1 January 2024. Deadlines have been set for the submission of different types of dossiers.

Dossiers for the Research and Development Division (human use)

A clock stop will be applied from 23 December 2023 to 7 January 2024: a 16-day delay will be added for all procedures. All dossiers submitted during this clock stop will be processed from 8 January 2024 onwards. – medical device (meddev)/clinical investigation (CI) dossiers

Dossiers for other divisions at the FAMHP: –Tuesday 12 December 2023 is the deadline to submit dossiers to the following divisions. The validation procedure for dossiers submitted after 12 December 2023 will start on 2 January 2024.

-The Marketing Authorisation Division (human use) and (variations and renewals).

CANADA

Revised notice on Implementing the regulatory enrolment process (REP) for medical devices regulatory activities

The Health Products and Food Branch (HPFB) is implementing the regulatory enrolment process (REP) and use of the Common Electronic Submissions Gateway (CESG) for medical device regulatory activities. Our decision is based on the results of a pilot project, which began in November 2019 and will end in June 2024. About 40 companies participated in the pilot.

The pilot was positive. All medical device companies are now invited to begin to use this process beginning in July 2024.

Guiding principles on Predetermined change control plans for machine learning- enabled medical devices

Predetermined change control plans for machine learning-enabled medical devices document, FDA, Health Canada and MHRA jointly identified 5 guiding principles (Focused and bounded, Risk- based, Evidence-based, Transparent, Total product lifecycle perspective) for predetermined change control plans. These principles draw upon the overarching good machine learning practice (GMLP) guiding principles.

Advancements in digital health technologies include artificial intelligence/machine learning- enabled medical devices (MLMDs). Regulatory expectations that are aligned with best practices for development and change management, such as those described in the GMLP guiding principles, can help to support the quality of such devices. Ultimately, this can lead to patient benefits such as earlier access to innovative technologies or more accurate diagnoses.

Updates to the guidance on medical device establishment licensing (GUI-0016)

On September 6, 2023, Health Canada’s Regulatory Operations and Enforcement Branch revised the guidance on regulatory requirements in relation to the medical device establishment licence (MDEL). incorporated the applicable sections of paragraphs 45 (h) and 45 (h.1) in the amended Medical Device Regulations (MDR) introduced sections 62.21 to 62.26 aligned an MDEL requirement with the MDR clarified various sections of the document including submitting MDEL amendments.

This guidance document covers licensing requirements for MDELs, including who requires an MDEL. It describes how to:

apply for an MDEL
- submit an annual licence review before April 1 of each year make change(s) to your existing licence (for example, an amendment or section 48 notification
- cancel your MDEL
- reinstate your licence after a suspension.

Medical Devices Licence Amendment Minor Change Form – Guidance for Changes to the Manufacturer’s Name and / or Address of Existing Device Licenses and/or COVID-19 medical device authorizations

Manufacturers of an existing medical device licence (MDL) and/or COVID-19 medical device authorizations wishing to make changes to a name or address must use our minor change form. The form contains more information on what’s required.

Medical Device License Application Review Fee Form

Refer below link for the Medical Device Application fee form.

CZECH REPUBLIC

Updated versions of the information and advisory guidelines for the advertising of medical devices and in vitro diagnostic medical devices

The institute draws attention to the published updated versions of information and recommended guidelines for advertising medical devices and in vitro diagnostic medical devices, which are also available at https://www.sukl.cz/sukl/obecne-pokyny-a-formulare. The information and recommendations are updated due to the changes made by the amendments in the legislation concerning medical devices and in vitro diagnostic medical devices.

EUROPE

Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices

Commission Implementing Regulation (EU) 2023/2713 of 5 December 2023 designating European Union reference laboratories in the field of in vitro diagnostic medical devices

The laboratories listed in the Annex are designated as EU reference laboratories for the specific devices or a category or group of devices, or for specific hazards related to a category or group of devices, as specified in that Annex.

Update – Rev 1 – MDCG Position Paper: Notice to manufacturers and notified bodies to ensure timely compliance with MDR and IVDR requirements

With the adoption of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR), the regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has significantly changed. The main objectives of these two Regulations are to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices and in vitro diagnostic medical devices which ensures a high level of safety and health whilst supporting innovation.

Enhancing the capacity of notified bodies and the efficiency of conformity assessment procedures remain a top priority for the MDCG. The actions listed in MDCG 2022-14 are showing good results,

To date, 40 and 12 notified bodies are designated under the MDR and the IVDR respectively. The efficiency of the designation process has improved, and individual notified bodies have increased their internal capacity to be able to handle more applications for conformity assessment.

EUDAMED user guide – UDI Devices

The EC release the EUDAMED Production notes V 2.13 – 2023

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI).

The UDI-DI/Device module of EUDAMED is used for the manufacturers to provide their UDIs/Devices information and to make it available to everyone.

Commission Delegated Regulation (EU) 2023/2197 as regards the assignment of Unique Device Identifiers for contact lenses

Standard contact lenses

A UDI-DI shall be assigned to standard contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (“Master UDI-DI”).

Made to order contact lenses

A UDI-DI shall be assigned to made to order contact lenses that have the same combination of contact lens design parameters, including at least base curve and diameter (“Master UDI-DI”). In addition to the requirement laid down in Section 3.9, a new Master UDI-DI shall be required whenever there is a change in the combination of the design parameters referred to in the first paragraph.

MDCG 2023-4 – Medical Device Software (MDSW) – Hardware combinations Guidance on MDSW intended to work in combination with hardware or hardware components

Through the provision of information and/or signals, these hardware or hardware components play an essential role in contributing to the medical purpose of certain MDSW. It is important to consider how the manufacturer of the MDSW has to demonstrate conformity with the applicable regulatory requirements for the combination of the MDSW and the concerned hardware or hardware components.

This guidance intends to examine and provide clarifications on which specific regulatory considerations apply when the hardware or hardware component incorporating the data collection element (camera, electrical/optical sensors etc.) are a medical device or an accessory to a medical device.

Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR

This Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing Regulation (EU) 2022/23461, as amended by Commission Implementing Regulation (EU) 2023/11942. Transitional provisions set out in the MDR have been extended by Regulation (EU) 2023/6074 that also sets out conditions for benefitting from those extended transitional periods. The amended transitional provisions apply from 20 March 2023.

Considering that transitional provisions for products covered by a certificate issued by a notified body in accordance with Council Directive 93/42/EEC (MDD)5 are set out both in the amended MDR and in the CS, Commission Implementing Regulation (EU) 2023/1194 has been adopted to align the transitional provisions set out in the CS to those set out in the amended MDR. The content of this document has been drafted considering the requirements applicable from the amended MDR and the amended CS.

Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period

The flowchart is intended to assist manufacturers and other relevant actors in deciding whether or not a device is covered by the extended transitional period provided for in Article 120 of Regulation (EU) 2017/745 on medical devices (MDR), as amended by Regulation 2023/607. The flowchart should help to determine the eligibility, conditions and deadlines for the placing on the market or putting into service of certain devices in accordance with Article 120 MDR. The user of the flowchart is advised to consult the text of the MDR, which takes precedence over the flowchart, and the Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607.

Updated – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices

The MDR replaced the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The MDR became applicable on 26 May 2021.

The IVDR replaced the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The IVDR became applicable on 26 May 2022.

Both Regulations provide for additional transition periods, under certain conditions. The requirements enter into application gradually, starting with the provisions related to the designation of notified bodies and the ability of manufacturers to apply for certificates under the Regulations.

The MDR and the IVDR are directly applicable to all EU Member States and therefore create a level playing field across the EU market.

New publication of Harmonised standards under the medical devices Regulations

Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the basis of a Standardisation Request issued by the Commission according to Regulation (EU) No 1025/2012EN. Once their references are published by the Commission in the Official Journal of the European Union, the voluntary use of those standards confer presumption of conformity with the requirements of the Regulations they aim to cover.

Add 1 -MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate

The position paper MDCG 2022-18 was published in December 2022 to provide a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a certificate issued under Directive 93/42/EEC (MDD) or Directive 90/385/EEC (AIMDD) has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR. The use of Article 97 MDR in those situations was meant to be a temporary solution. The goal of the position paper MDCG 2022-18 was to contribute to avoiding disruption of supply of devices on the EU market needed for health systems and patients.

Regulation (EU) 2023/607 has averted the imminent risk of shortages of critical legacy devices related to the expiry of MDD/AIMDD certificates.

The MDCG recommends that national CAs limit the application of Article 97 MDR as set out in MDCG 2022-18 to very exceptional situations, e.g. where the national competent authority (CA) has received information justifying the application of Article 97 MDR prior to 20 March 2023.

Template for NB -Confirmation letter in the framework of Regulation (EU) 2023/607

Confirmation of the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation EU 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices.

This letter confirms that, NB Name, a Notified Body (NB) designated against Regulation (EU) 2017/745 (MDR) and identified by the number XXXX on NANDO, has received a formal application in accordance with Section 4.3, first subparagraph of Annex VII of MDR and has signed a written agreement in accordance with Section 4.3, second subparagraph of Annex VII of MDR with the following manufacturer.

Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical Device Regulation (EU) 2017/745

This best practice guidance document has been developed by members of Team NB who have reviewed the best practice guidance documents submitted by individual Team NB notified body members, with the purpose to develop a unified approach on the expectations of technical documentation submissions from manufacturers.

This technical documentation submission guidance is aligned to the requirements of Medical Devices Regulation [MDR] (EU) 2017/745, described in detail in Annexes II and III of Regulation (EU) 2017/745.

Principles and Practices for Software Bill of Materials for Medical Device Cybersecurity

This document considers cybersecurity in the context of medical devices that either contain software, including firmware and programmable logic controllers (e.g., pacemakers, infusion pumps) or exist as software only (e.g., Software as a Medical device (SaMD)). The document emphasizes the roles and responsibilities of MDMs and HCPs and provides recommendations on the implementation of an SBOM and increased transparency in the use of software in medical devices, including in vitro diagnostic (IVD) medical devices. While primarily focused on MDMs and HCPs, we believe that other stakeholders, including but not limited to medical device users, regulators, and software component vendors, may also find the concepts discussed in this document useful Protection of the cyber healthcare environment is a shared responsibility of HCPs and MDMs. The SBOM is a common tool to support safety as it can help to mitigate against the potential for patient harm. This document is intended to:

Provide recommendations for medical device manufacturers in SBOM generation, management, and distribution.
Provide recommendations to healthcare providers on ingestion and management of an SBOM.
Demonstrate SBOM use cases for risk management, vulnerability management, and incident response from the perspective of medical device manufacturers and healthcare providers.

Principles and Practices for the Cybersecurity of Legacy Medical Devices

This document is designed to provide concrete recommendations on how to apply the TPLC to legacy devices to aid in the implementation of the framework put forward in the preceding IMDRF N60 guidance. This document is complementary to the IMDRF N60 guidance, and the scope of relevant medical devices (including in vitro diagnostic (IVD) medical devices), as well as the focus on potential for patient harm remain unchanged.

It considers cybersecurity in the context of legacy medical devices that either contain software, including firmware and programmable logic controllers (e.g., pacemakers, infusion pumps) or exist as software only (e.g., Software as a Medical device (SaMD)). It is important to note that due to most regulators’ authority over medical device safety and performance, the scope of this guidance is limited to consideration of the potential for patient harm. For example, threats that could impact performance, negatively affect clinical operations, or result in diagnostic or therapeutic errors are considered in scope of this document. While other types of harm, such as those associated with breaches of data privacy, are important, they are not considered within the scope of the document.

Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions

Regulation (EU) 2023/607EN of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices. The Regulation introduces a staggered extension of the transition period provided for in Regulation (EU) 2017/745 on medical devices (MDR), subject to certain conditions. It also deletes in both MDR and IVDR the “sell-off” deadline after which devices placed on the market before or during the transition periods that are still in the supply chain would have had to be withdrawn.

Guideline on computerised systems and electronic data in clinical trials

The European Medicines Agency (EMA) has finalized a guideline on computerized systems and electronic data in clinical trials. EMA’s document, which replaces a reflection paper on the same topic, is intended to help stakeholders adapt to increases in the complexity of computerized systems that have happened in recent years.

In setting out the need for guidance, EMA pointed to the rapid changes that have occurred as electronic case report forms, electronic patient reported outcomes, wearable devices and artificial intelligence have become part of the clinical trial landscape. EMA has designed the guidance to help stakeholders use the new technologies while ensuring the quality and reliability of trial data, and the rights, dignity, safety and wellbeing of trial participants.

MDCG 2023-3 – Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices

This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). Establishing a common understanding of these terms and concepts is necessary for an effective and harmonised implementation of the vigilance requirements under the MDR.

The document is non-exhaustive and should be read in conjunction with the MDR, relevant standards and MDCG guidance documents. Terms and concepts that are outlined in the corresponding articles of the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this document.

DIRECTIVE (EU) 2022/2555 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148 (NIS 2 Directive)

Directive (EU) 2016/1148 of the European Parliament and the Council aimed to build cybersecurity capabilities across the Union, mitigate threats to network and information systems used to provide essential services in key sectors and ensure the continuity of such services when facing incidents, thus contributing to the Union’s security and to the effective functioning of its economy and society.

In Medical Device Sector: Manufacture of medical devices and in vitro diagnostic medical devices

Entities manufacturing medical devices and entities manufacturing in vitro diagnostic medical devices with the exception of entities manufacturing medical.
Entities carrying out research and development activities of medicinal products
Entities manufacturing basic pharmaceutical products and pharmaceutical preparations
Entities manufacturing medical devices considered to be critical during a public health emergency (public health emergency critical devices list)

Coverage of designation codes by MDR/IVDR notified bodies – January 2023

Designation Codes coverage by MDR/IVDR notified bodies

Summary MDR codes coverage:

More than 80% of codes are covered by more than 20/36 NBs. Just 5 codes are covered by less than 1/3 NBs:

MDA 0102: Active implantable devices delivering drugs or other substances
- MDA 0104: Active implantable devices utilising radiation and other active implantable devices
- MDA 0103: Active implantable devices supporting or replacing organ functions
- MDA 0101: Active implantable devices for stimulation/inhibition/monitoring
- MDS 1002: Devices manufactured utilising tissues or cells of human origin, or their derivatives

Summary IVDR codes coverage:

Over 80% of codes are covered by 7/8 NBs;
- Only one code is covered by 5/8 NBs:
- IVD 4010: In vitro diagnostic devices which require knowledge regarding mycology

MDCG 2023-2 – List of Standard Fees

MDCG clarified the meaning of “publicly available”, which “implies that a member of the public can access this information at any point in time, without the need for additional steps.” (MDCG guidance 2019-6 section V.2.).

This implies the list of fees of each notified body should be directly and easily accessible on the website of the notified body without any additional steps, e.g. without the need to register as a user of the website or provide contact data. This website should be the website registered for the notified body on NANDO and not a different website of another organization. The format of the standard fee table could be any that is accessible on a common website browser.

The currency shown should be relevant to the country where the notified body has its registered place of business (in line with the information provided in NANDO). If there are regional differences in fees charged depending on the location of manufacturer, this should also be indicated.

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

Reasons for and objectives of the proposal

Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) of the European Parliament and of the Council establish a reinforced regulatory framework for medical devices and in vitro diagnostic medical devices. Their objectives are a high level of protection of health for patients and users and the smooth functioning of the internal market for these products.

To achieve these objectives and, in light of issues identified with the previous regulatory framework, the Regulations set out a more robust system of conformity assessment to ensure the quality, safety, and performance of devices placed on the EU market.

FINLAND

Medical device operator: check the information entered in the register for the control fee to be collected in 2024

In accordance with Section 50 of the Medical Devices Act (719/2021), Fimea collects a monitoring fee from operators of medical devices who are required to report annually. The monitoring fee is charged separately for each registered role. So if you operate as a distributor and a manufacturer, for example, you will receive an invoice containing two monitoring fees.

Operators have the obligation to notify Fimea of material changes in the information they provide. The monitoring fee for 2024 is determined based on the information reported by the end of 2023. The monitoring fee is charged, unless the operator has not notified CERE or EUDAMED electronically by December 31, 2023, of the end of the activity for the registered activity. Notification to CERE can also be made to Fimea in writing. However, the monitoring fee is not charged if Fimea has otherwise declared that the operation has ended by 31 December 2023.

Fimea named a new notified body in Finland in accordance with the IVD regulation

Fimea has named Sertio Oy from Tampere as a notified facility in accordance with the regulation on medical devices intended for in vitro diagnostics (2017/746, IVD regulation). This was already the second Finnish designation according to the IVD regulation. To date, twelve notified institutions in accordance with the IVD Regulation have been named throughout the EU, of which two are now in Finland. The nomination was published on the European Commission’s website in the Nando database on October 31, 2023. This can be considered a significant issue for the Finnish and European diagnostics industry.

Notified institutions are independent external assessment institutions that carry out conformity assessments in accordance with the regulation. In order to act as a notified body according to the regulation, the designation must be applied for from the national authority.

Extension of the transition periods for requirements for products such as medical devices

Annex XVI of the Medical Devices Regulation defines products that do not have a medical purpose, but which are similar in function and risk profile to medical devices. This product group includes, for example, fillers used in the beauty care industry and light impulse devices for hair removal. The validity of the transitional regulations for these products has been extended by the implementing regulation published in June.

The regulation has been applied since June 22, 2023. The validity of the transitional provisions will be extended until December 31, 2028 or December 31, 2029. The length of the transition period depends on whether the product is undergoing a clinical trial or not. Transition periods only apply to products whose conformity assessment requires the participation of a notified body. From the date of application of the regulation, the notified body can issue a certificate in accordance with the MD regulation for the products of Annex XVI.

The amending decree extending the transition periods of the medical device regulations entered into force

The amending regulation approved by the EU Council on March 7, 2023, which conditionally extends the validity periods of certificates in accordance with medical device directives, has been published in the EU’s official journal and entered into force on March 20, 2023.The decree also removes the restrictions on the last date for the sale of medical devices and in vitro diagnostic devices in accordance with the directives. These measures will reduce the possible risk of a shortage of medical equipment.

In order to take advantage of the new transition periods, devices and manufacturers must meet certain conditions. These conditions aim to ensure that the additional time is only applied to devices that are safe and for which the manufacturers have already started the certification process.

GREECE

Notice regarding the transitional provisions of Reg. (EU) 2017/745 on Medical Devices (M/D)

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.

ITALY

Recommendation for manufacturers of in vitro diagnostic medical devices

The various discussions at European level have highlighted a picture deserving of extreme attention due to the approaching deadlines for the implementation of the IVDR. In fact, in relation to the certification times indicated by the Notified Bodies, there appears to be a situation of delay in the submission of the files to the Notified Bodies, in particular for class D IVDs.

For these reasons, the Ministry of Health, the competent authority for in vitro diagnostic medical devices, taking into account any critical issues that could arise in relation to the availability of these products with a consequent impact on the health of citizens, invited, with the note of 12 December 2023 , Italian companies manufacturing in vitro diagnostic medical devices to accelerate the process of adapting to community legislation and not to further procrastinate the submission of certification applications, especially for class D devices.

Obligations of registration and storage of the unique device identifier (UDI) by healthcare institutions and healthcare professionals

The decrees provide for the obligation to register and store the UDI, in electronic form, for health institutions and for health professionals who do not exercise their professional activity in the context of a health institution.

For medical devices in particular, the decree:

reiterates the obligation already established in Regulation (EU) 2017/745 for all class III implantable medical devices that institutions and healthcare professionals have supplied and received
introduces the same requirement for all class III and class IIb implantable medical devices

The decrees also indicate the possibility of registering and storing UDIs for all medical devices and in vitro diagnostic medical devices, including those belonging to other risk classes, on a voluntary basis.

LATVIA

New rules for in vitro diagnostic medical devices come into force

The State Medicines Agency informs that this year On October 13, the regulations of the Cabinet of Ministers of October 10, 2023 No. 582 “Regulations for in vitro* diagnostic medical devices”

The new regulations on in vitro diagnostic medical devices have been adopted to implement the obligations arising from the norms of Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices (hereinafter – Regulation 2017/746).

Custom-made medical devices, registration of manufacturers

The Decree of the Minister of Health of 9 June 2023 has been published in the Official Journal which identifies the methods for providing information regarding the manufacturer’s identification data and the list of types of customized medical devices made available on the national territory, pursuant to the Regulation (EU) 2017/745.

The decree provides that the registration of manufacturers of customized medical devices in the list of the Ministry of Health takes place exclusively online.

The methods of communication of information are established, referred to in article 7 of the legislative decree of 5 August 2022, n. 137, relating to the manufacturer’s identification data and the list of types of customized medical devices that manufacturers make available on the national territory. The decree also establishes the retention times of the manufacturer’s personal data.

The decree provides transitional provisions for the online registration of manufacturers already registered in the existing lists of the Ministry of Health.

NEW REGULATIONS ON MEDICAL DEVICES COME INTO FORCE

The State Medicines Agency informs that today, on August 23, 2023, the Cabinet of Ministers Regulation No. 461 of August 15, 2023 ” Medical Device Regulations ” came into force.

The new regulations on medical devices have been adopted to implement the obligations arising from the norms of Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (hereinafter – Regulation 2017/745).

NEW RULES FOR CLINICAL AND IN VITRO DIAGNOSTIC PERFORMANCE STUDIES OF MEDICAL DEVICES COME INTO FORCE

The State Medicines Agency informs that today, on August 23, 2023, the Cabinet of Ministers’ regulations of August 15, 2023 No. 455 ” Procedure for conducting clinical studies of medical devices intended for humans and performance studies of in vitro diagnostic medical devices “.

The new regulations have been adopted to implement Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (hereinafter – Regulation 2017/745) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereinafter – Regulation 2017/ 746) obligations resulting from norms in the field of clinical trials and performance studies.

SLOVAKIA

Notice for manufacturers, authorized representatives, importers or distributors of medical devices or in vitro diagnostic medical devices

The State Institute for Drug Control (SUKL) warns manufacturers, authorized representatives, importers or distributors of medical devices or in vitro diagnostic medical devices that:

In accordance with 110b par. 2 of Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts, a manufacturer, authorized representative, importer or distributor who makes a medical device or in vitro diagnostic medical device available on the market in the Slovak Republic according to special regulations, 72a) is in in electronic or paper form, obliged to notify this fact to the state institution within 14 days of the first access medical device or in vitro diagnostic medical device on the market in the Slovak Republic by submitting the information and documentation necessary to demonstrate the conformity of the medical device or in vitro diagnostic medical device, which are a standardized form, EU declaration of conformity, conformity assessment certificate, outer packaging and manual; this obligation does not apply to making available a class I medical device and a class A in vitro diagnostic medical device, if the state institute does not request them to notify and send these documents.

Obligation for the manufacturer, authorized representative, importer or distributor to notify the State Institute for Drug Control of the information and documentation necessary to prove the conformity of the medical device or in vitro diagnostic medical device for making the medical device or in vitro diagnostic medical device available on the market in the Slovak Republic

ISSUANCE OF FREE SALE CERTIFICATES (FSC) FROM 1 AUGUST 2023 BASED ON THE AMENDMENT TO ACT 362/2011 COLL. (ACT 293/2023 COLL.)

On the basis of §129 paragraph 2, letter j) of Act 362/2011 Coll. on medicines and medical devices in the version effective from 1 August 2023 (amendment 293/2023 Coll.), ŠÚKL is again authorized to issue free sale certificates (FSC) for manufacturers/authorized representatives (EC-REP based in the Slovak Republic) for medical devices /diagnostic medical devices in vitro.

SPAIN

The AEMPS reports on the new CNCps procedure to confirm the validity of certificates issued in accordance with MDD

The Spanish Agency for Medicines and Health Products (AEMPS) informs of the new procedure established by the National Center for Certification of Health Products (CNCps) to confirm that manufacturers have a written agreement for the certification of health products according to the MDR, one of the necessary conditions to be able to continue marketing these products according to the new measures taken by the European Commission.

These standards will serve to guarantee the availability of medical devices on the market once the validity date of the CE marking certificates under which they are marketed has passed, publishing on March 20, Regulation (EU) 2023/607. This regulation extends the transitional period during which “legacy” medical devices compliant with directive 93/42/EEC (MDD) can be legally placed on the market provided certain conditions are met. To facilitate the correct interpretation of the conditions established for the extension, the question and answer guide has been published.

SWITZERLAND

Information sheet Clinical investigations with medical devices

Medical devices, accessories for medical devices, and devices without a medical purpose listed in Annex I of the MedDO are referred to as ‘medical devices’ in this information sheet. This information sheet is valid under the new regulation that came into force on 26 Mai 2021 and it is intended for sponsors of clinical investigations of devices, contract research organisations (CROs), and investigators. It provides guidance on the authorisation process, reporting requirements of sponsors, and the surveillance of clinical investigations by the Swiss Agency for Therapeutic Products, Swissmedic.

The Swiss Human Research Act (HRA, SR 810.30) regulates biomedical research on human subjects and is based on internationally recognised principles. It shall in particular ensure that

the investigational medical device must demonstrate a sufficient stage of development for its intended use on humans.
the investigation must satisfy scientific and ethical criteria
the dignity, personality and health of human subjects must be protected

Information sheet – Products without an intended medical purpose

Certain products without an intended medical purpose that are used to change a person’s appearance have been governed by the Medical Devices Ordinance since 26 May 2021. These include, for example, coloured contact lenses, products for lipolysis and dermal filling and laser devices for skin resurfacing The Information sheet is intended to help manufacturers, importers, authorised representatives and users of products without an intended medical purpose to understand the new regulatory requirements and comply with the transitional provision.

Stricter regulation of manufacturing, marketing and use is required to better guarantee the safety of the people using or applying these products. This is particularly important given that some of these products may be used by non-professional users at home.

Swissdamed – Swiss Database on Medical Device

The swissdamed application – the Swiss Database on Medical Devices – is a Swissmedic IT system that makes it possible to apply the Swiss regulations on medical devices and in vitro diagnostic medical devices.

It is structured around two interconnected modules; which only registered users can access. It also includes a freely accessible search function.

Registration of companies and economic operators – ACT module (available early 2024)
Swissdamed – freely accessible platform (available early 2024)
Registration of devices – UDI module (available from summer 2024) The above modules will be made available in different releases.

Requirements for the maintenance of sterile containers (sterilization containers according to SN EN 868-8)

The aim of this leaflet is to specify the requirements for the maintenance of sterile containers according to SN EN 868-8 in order to ensure that maintenance is carried out periodically according to the manufacturer’s instructions and taking into account the risks inherent in the product, and that product and patient safety is guaranteed accordingly. During AEMP inspections in hospitals, Swissmedic repeatedly finds that sterile containers are not maintained in accordance with regulations and that non-functional sterile containers continue to be used.

Reusable sterile containers (sterilization containers) according to the standard SN EN 868-8 “Packaging for medical devices to be sterilized in the final packaging – Part 8: Reusable sterilization containers for steam sterilizers according to EN 285 – Requirements and test methods” are final packaging for medical devices to be steam sterilized, used invasively.

MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

In view of bottlenecks at the notified bodies, these amendments implemented a number of measures in the EU, including extension – under certain circumstances – of the validity of certificates issued under the old legislation until 2027/2028 (depending on classification) and lifting of the deadlines for putting into service and placing on the market (EU-MDR and EU-IVDR).

Until then, as part of its enforcement of therapeutic products legislation, Swissmedic will tolerate the placement of devices on the market in Switzerland which are covered by a valid certificate according to the MDR and IVDR amendments. Anticipating the amendments to the ordinances in enforcement prevents discrepancies in market supply conditions between Switzerland and the EU and ensures legal compliance during the transitional phase. These measures ensure that the devices marketed in the EU continue to be available for Swiss patients.

MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured

During the transitional phase, until the Medical Devices Ordinance (MedDO) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO) are amended, Swissmedic is already going ahead with enforcement according to the EU amendment to avoid jeopardising the supply of medical devices in Switzerland. In the EU, amendments of the EU-MDR 2017/745 regarding transitional periods for certificates, and of the EU-MDR and EU-IVDR 2017/746 regarding the elimination of deadlines for putting devices into service and placing on the market, were published on 20th March 2023.

Dealing with certification gaps (MDCG 2022-18)

Swissmedic (Switzerland’s competent authority for medical devices) implements the medical device legislation (Medical Devices Ordinance; MedDO; SR 812.213) equivalent to the EU in order to ensure an equivalent level of safety.

MDCG 2022-18 aims to achieve a common understanding of and a uniform approach to the application of Article 97 of Regulation (EU) 2017/745 on medical devices (MDR) in situations where a device is not in conformity with the MDR because its certificate issued under the previous legislation (Directives 93/42/EEC; MDD and 90/385/EEC; AIMDD) expires before issuance of the necessary certificate(s) in accordance with the new legislation (certification gap) Where such a device does not present an unacceptable risk to health and safety, Article 97 MDR enables competent authorities to require the relevant manufacturer, or its authorized representative, to bring the non-compliance to an end within a reasonable and clearly defined period.

UNITED KINGDOM

The Innovative Devices Access Pathway (IDAP)

The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market.

Update

Updated to add that the IDAP Pilot is closed for applications.

Register medical devices to place on the market

How to register your medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland

Update

Clarification concerning fees and actions required to change legislation of a registered device.

MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers

The AI-Airlock will assist in the development and deployment of software and AI medical devices, safely providing patients with earlier access to cutting edge innovations that improve care.

It follows a robust process, so manufacturers of software and AI medical devices understand and deliver what is required to ensure the real-world viability of these devices. The process, following the ‘regulatory sandbox’ model is a world-leading mechanism to assist in safe development and deployment of software and AI medical devices.

This initiative demonstrates the MHRA’s commitment to building on its existing capabilities and investing its regulatory expertise to enable highly innovative areas of medical product development, bringing cutting-edge products to UK patients faster, without compromising on its robust standards of safety and performance.

MHRA and international partners publish five guiding principles for machine learning- enabled medical devices

The Medicines and Healthcare Products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.

The MHRA, FDA and Health Canada have today published five guiding principles for the development of PCCPs for MLMD manufacturers. These guiding principles aim to support manufacturers of MLMDs by reducing the regulatory burden of reassessment following certain changes and updates to their devices.

Medical devices: EU regulations for MDR and IVDR (Northern Ireland)

The guidance explains about Information about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland.

Update

Updated to include Medical devices: Clinical investigations and performance studies in Northern Ireland replacing Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland.

Three new UK Approved Bodies to certify medical devices announced by the MHRA

The Medicines and Healthcare Products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare professionals and the public.

Before appointing an Approved Body, the MHRA conducts a detailed assessment process to ensure that organizations are stable and able to undertake impartial and objective conformity assessment activities, that they have an appropriate quality management system, the capacity and competence to undertake assessments and the processes they use meet the relevant regulatory requirements.

After successful designation, the MHRA monitors UK approved bodies’ activities including by regular audits and by witnessing some of their audits of manufacturers.

For any organisations wanting to become an approved body, please contact info@mhra.gov.uk.

Notify the MHRA about a clinical investigation for a medical device

The guidance explains about How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.

Update

Added information on fees payable in relation to clinical investigation and amendments to clinical investigations

Medical devices: UK approved bodies

UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Update

Published – Intertek Medical Notified Body UK Ltd Medical Devices Scope.

Export medical devices

Order a certificate of free sale to export medical devices outside the UK. You may need a Certificate of Free Sale (CFS) to export medical devices. To find out, check the import rules of the country you are exporting to. Talk to your importer or get help researching your export market.

The MHRA only issues a CFS as a service to UK exporters for medical devices. If you need a CFS for other products, contact the Department for Business and Trade (DBT).

Update

Updated: Certificates of Free Sale for Medical Devices reference guide

Medical devices: guidance for manufacturers on vigilance

Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.

Adverse incidents involving medical devices that occur in the UK must be reported to the Medicines and Healthcare Products Regulatory Agency (MHRA). The MHRA is responsible for the UK medical device market. Once a medical device has been placed on the UK market, the manufacturer must submit vigilance reports to the MHRA when certain types of incidents that involve their device occur in the UK. The manufacturer must also take appropriate safety action when required. The manufacturer will need to ensure their device meets appropriate standards of safety and performance for as long as it is in use.

The notification and evaluation of adverse incidents and field safety corrective actions (FSCA) involving medical devices is known as the medical device vigilance system. Comprehensive information on the medical device vigilance system is given in MEDDEV 2.12/1 rev 8 and the additional guidance under ‘Post-Market Surveillance’, and describes what, how and when to report adverse incidents involving medical devices on the UK market.

Update

Guidance updated to reflect the latest information regarding the MORE portal.

CE marking recognition for medical devices and in vitro diagnostics

The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. The extended recognition of CE marking does not apply to medical devices or IVDs. The government has already put in place legislation that amends The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR) to extend the acceptance of CE marked medical devices on the Great Britain market. More specifically, legislation now enables CE marked medical devices to be placed on the Great Britain market.

general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2028
in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of the expiry of the certificate or 30 June 2030, and
general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.

Implementation of medical devices future regime

MHRA is aiming for core aspects of the future regime for medical devices to apply from 1 July 2025. On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The response outlined the intended regulatory reform including the transitional arrangements for CE and UKCA marked devices placed on the Great Britain market. This page provides an update on the timelines to implement the future Medical Device Regulations.

The approach to this reform was outlined in the government response to the 2021 consultation on the future regulation of medical devices in the UK. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimizes the risk of supply disruption for UK patients. This guidance has been updated to reflect that the government is now aiming for core aspects of the future regime for medical devices to apply from 1 July 2025.

Update: Updated guidance to reflect that the World Trade Organization (WTO) has published the draft Post Market Surveillance Requirements Statutory Instrument.

Notice regarding the transitional provisions of Reg. (EU) 2017/745 on Medical Devices (M/D)

Regulating medical devices in the UK

The guidance explains about what you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

This guidance provides information on the UK system, including for:

getting your device certified
conformity marking your device
registering your device with the MHRA

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland. Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.

Update: Registrations guidance links updated.

Medical devices regulations: compliance and enforcement

MHRA has the responsibility to check that medical devices in the UK comply with legal requirements.

This guidance includes:

contact details to report a non-compliant medical device
information on MHRA’s enforcement duties after receiving a complaint MHRA’s routine monitoring role

MHRA is the designated authority that administers and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure their safety and quality. The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

UPDATE: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

Guidance on Class I medical devices

Advice for manufacturers of Class I medical devices for placing products on the UK market

This guidance applies to manufacturers of Class I medical devices, including accessories but excluding devices intended for clinical investigation and custom-made devices. This guidance is divided into sections on the different rules that apply in Great Britain (England, Wales and Scotland) and Northern Ireland. For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see the section on Class I devices in Northern Ireland below.

CE marked medical devices continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030.You will be able to self-certify your Class I medical device for the CE mark, and place your device on the Great Britain market. You will not require an Authorized Representative if you are solely placing your Class I device on the Great Britain market. If you are self-certifying your Class I medical device for the CE mark, you will need to meet the requirements of the Medical Devices Regulation (2017/745) from 26 May 2021. See our guidance for more information on the use of the CE mark for Great Britain.

The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Medical devices: legal requirements for specific medical products

Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices.

Read this for information on how to comply with the legal requirements for prosthetic, orthotic and ophthalmic devices. The guidance includes:

classification
custom-made prosthetic, orthotic and ophthalmic devices
examples

This guidance is specific to medical devices placed on the market in Great Britain. For guidance on the legislation applicable to medical devices in Northern Ireland, please see our published guidance. The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime

UPDATE: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

Timeframe for accepting CE marked medical devices in Great Britain extended

CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023.

The Government has made regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023.This measure aims to support the ongoing and safe supply of medical devices within Great Britain and facilitate a smooth transition towards a future strengthened regulatory framework for medical devices.

It is the first statutory instrument in a series that are planned to implement the strengthened framework. Next in the series, the MHRA intends to lay a statutory instrument later this year that will put in place enhanced post-market surveillance requirements.

Link

Approved bodies for medical devices

Guidance on what approved bodies are, what they do and how you can become one.

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the designating and competent authority in the UK.

An approved body is an organization that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Manufacturers can apply to any UK approved body and once they have the necessary certification their products can be sold anywhere in Great Britain (England, Wales and Scotland). Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to place UKCA marking on their products and place them on the market in Great Britain.

MHRA / HRA Coordinated pathway

The Medicines & Healthcare products Regulatory Agency (MHRA) and the Health Research Authority (HRA) are please to confirm that the Coordinated pathway process will resume Monday 22 May 2023.

The MHRA in partnership with the HRA can offer a new coordinated assessment pathway which will streamline the review of clinical investigations involving medical devices. This assessment pathway will benefit applicants by ensuring the MHRA review, and the Research Ethics Committee (REC) review are undertaken in parallel, and information will be shared. MHRA is collaborating with the HRA on the coordinated assessment pathway which involves our two organisations sharing information during our assessment of medical device clinical investigations. For this process we require the MHRA Devices application to be submitted first and then the REC application to be submitted as soon as MHRA has confirmed the devices application to be valid.

The Medical Devices Amendment 2023 No. 627 Statutory Instruments

Effective for, 1 July 2023 the UK are giving additional time to manufacturers and importers to place CE marked Medical devices on the Market in Great Britain (GB). The Manufactures can also use the UKCA Conformity assessment route too.

Notify the MHRA about a clinical investigation for a medical device

The guidance explains about How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.

Update:- Updated info on ‘MHRA / HRA Coordinated pathway’ – Resuming Monday 22 May 2023.

Approved bodies for medical devices

Guidance on what approved bodies are, what they do and how you can become one.

The government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. For more detail on this see the implementation update on work towards a strengthened future medical devices regime. The Medicines and Healthcare Products Regulatory Agency (MHRA) is the designating and competent authority in the UK.

Update

Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Medical devices: off-label use

This guidance is only relevant for medical devices on Great Britain (England, Wales and Scotland). Please note that we will continue to accept CE marked devices on the Great Britain market until 30 June 2023. Currently, from 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements.

The government does intend to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Update: Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

Guidance on Class I medical devices

Advice for manufacturers of Class I medical devices for placing products on the UK market.

For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see the section on Class I devices in Northern Ireland below. CE marked devices will currently continue to be accepted on the Great Britain market until 30 June 2023. You will be able to self-certify your Class I medical device for the CE mark, and place your device on the Great Britain market. You will not require an Authorized Representative if you are solely placing your Class I device on the Great Britain market. If you are self-certifying your Class I medical device for the CE mark, you will need to meet the requirements of the Medical Devices Regulation (2017/745) from 26 May 2021. See our guidance for more information on the use of the CE mark for Great Britain.

Update: Paragraph added to this page which explains that the government intends to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023.

MHRA fees

Fees payable to the MHRA for 2023 to 2024

UPDATE: – Amendment fees added to our ‘Current MHRA fees’ webpage.

Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU

The European Parliament has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates

Medical devices – extended acceptance of CE marked medical devices on the Great Britain market

A statutory instrument has been laid in Parliament, which will enable an extended timeframe for acceptance of CE marked medical devices on the Great Britain market. Subject to Parliamentary approval this will mean that CE marked medical devices will be accepted on the Great Britain market beyond the current deadline of 30 June 2023.

This will support the ongoing, safe supply of medical devices to Great Britain and is designed to ease the transition to a future strengthened regulatory framework for medical devices. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimises the risk of supply disruption for UK patients.

Extension of CE certificates

The EU has taken steps to give manufacturers more time to get certain medical devices certified under the EU Medical Devices Regulation (EU MDR).

Key changes include: Extension of the transitional period for higher-risk devices (class III and certain class IIb implantables), such as pacemakers, to comply with EU MDR requirements until 31 December 2027, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies). Extension of the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices), such as syringes, to comply with EU MDR requirements until 31 December 2028, subject to certain conditions (including requirements for post-market surveillance, quality management systems, and engagement with notified bodies).

USA

Digital Health Technologies for Remote Data Acquisition in Clinical Investigations

This guidance provides recommendations on the use of digital health technologies (DHTs) to acquire data remotely from participants in clinical investigations that evaluate medical products. DHTs for remote data acquisition in clinical investigations can include hardware and/or software to perform one or more functions. Use of DHTs as recommended in this guidance may improve the efficiency of clinical trials for sponsors, investigators, and other stakeholders and may increase the opportunities for individuals to participate in research and make participation more convenient.

Guiding Principles on Predetermined Change Control Plans for Machine Learning- Enabled Medical Devices

FDA, Health Canada, and MHRA jointly identified 5 guiding principles (Focused and bounded, Risk- based, Evidence-based, Transparent, Total product lifecycle perspective) for predetermined change control plans. These principles draw upon the overarching GMLP guiding principles, in particular principle 10, which states that deployed models are monitored for performance and re- training risks are managed.

Advancements in digital health technologies include artificial intelligence/machine learning enabled medical devices (MLMD). Regulatory expectations that are aligned with best practices for development and change management, such as those described in the GMLP Guiding Principles, can help to support the quality of such devices. Ultimately, this can lead to patient benefits such as earlier access to innovative technologies or more accurate diagnoses.

Guidance on Enforcement Policy for Non-Invasive Remote Monitoring Devices Used to Support Patient Monitoring

The enforcement policy described in this guidance applies to modified devices where the original device was a legally marketed, non-invasive remote monitoring device listed in the document. the listed devices are required to submit a premarket notification under section 510(k) of the FD&C Act to FDA and receive FDA clearance prior to marketing these devices in the United States, to the extent the devices are not 510(k) exempt, as well as comply with post-marketing requirements. This policy supports this strategic priority and is intended to lessen the burden on both manufacturers and FDA by reducing the number of 510(k) submissions caused by certain modifications to allow for remote monitoring.

Guidance on Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices

This guidance document provides a detailed description of the information that should be included in a premarket notification for a magnetic resonance diagnostic device (MRDD). This document is intended to be used in conjunction with information regarding the content and format of a 510(k) premarket notification.

The guidance reflects an update to harmonize with the 4th edition of the FDA recognized standard IEC 60601-2-33 Medical electrical equipment – Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis.

Guidance on Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment

Food and Drug Administration’s (FDA’s or the Agency’s) recommendations on testing to assess the safety and compatibility of medical devices in the Magnetic Resonance (MR) Environment and the recommended format for Magnetic Resonance Imaging (MRI) Safety Information in medical device labeling.

This guidance document applies to all medical devices that might be used in the MR environment. This includes all implanted medical devices, medical devices that are fastened to or carried by a patient (e.g., external insulin pump, pulse oximeter), medical devices that would reasonably be anticipated to enter the MR environment during clinical care, and all medical devices that are intended to enter the MR environment.

The recommendations in this guidance for MR labeling of devices are consistent with ASTM F2503 Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment.

Guidance on Electronic Submission Template for Medical Device 510(k) Submissions

FDA’s guidance document “Providing Regulatory Submissions for Medical Devices in Electronic Format — Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act provides a process for the development of templates to facilitate the preparation, submission, and review of regulatory submissions for medical devices solely in electronic format.

The guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that enable submission of the 510(k) electronic submission solely in electronic format. The electronic submission template includes the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary elements of a ‘complete’ submission, as required by regulation or essential to FDA’s substantive review of the 510(k) submission.

Enforcement Policy for Certain Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions

This policy applies to limited modifications made to a device approved through the PMA program that triggers the requirement that a manufacturer submit a PMA supplement or 30-day notice to FDA per section 515(d)(5)(A) of the FD&C Act and 21 CFR 814.39. This policy also applies to limited modifications made to a device approved through the HDE program that require a manufacturer submit an HDE supplement or 30-day notice to FDA per 21 CFR 814.108.

Examples of such modifications may include, but are not limited to:

Design and manufacturing changes to address component unavailability due to supply chain disruptions
- Manufacturing changes to allow the establishment to maintain operations and to accommodate social distancing in appropriate situations based on local conditions
- Changes in manufacturing facility or establishment

Changes to packaging procedures

Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling

The AST guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretive criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria website (STIC Website). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.

The scope of this guidance is limited to devices classified under 21 CFR 866.1640, 21 CFR 866.1645, or 21 CFR 866.1650 and does not include antimicrobial susceptibility test discs classified under 21 CFR 866.1620.12 The scope of this guidance is also limited to recommendations and marketing submission content expectations for PCCPs that include planned modifications to update AST system device labeling to include the updated breakpoints. This guidance does not describe recommendations for other planned modifications to AST system devices, including other planned modifications to update AST system device labeling unrelated to updating breakpoints. It is possible that other modifications could significantly affect the safety or effectiveness of the device and may require a new 510(k).

Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology

This document highlights technical considerations for the development of medical devices employing PCLC technology to ensure safe and effective use and provides recommendations for the content of premarket submissions (i.e., premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs), Humanitarian Device Exemptions (HDEs)) for such devices.

This guidance provides technical considerations related to the PCLC technology when designing PCLC medical devices. PCLC medical devices can include functions or components that have risks separate from the PCLC functions that are not addressed in this guidance. Not all considerations in this guidance will be applicable to every PCLC device given the variety of device types that can incorporate PCLC technology. Manufacturers should determine and justify in premarket submissions which considerations are appropriate for their device based on the technology being used and the intended use of the device.

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This guidance document is applicable to devices with cybersecurity considerations, including but not limited to devices that have a device software function or that contain software (including firmware) or programmable logic. The guidance is not limited to devices that are network-enabled or contain other connected capabilities. This guidance describes recommendations regarding the cybersecurity information to be submitted for devices under the following premarket submission types, when submitted to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER):

Premarket Notification (510(k)) submissions
De Novo requests;
Premarket Approval Applications (PMAs) and PMA supplements;
Product Development Protocols (PDPs);
Investigational Device Exemption (IDE) submissions;
Humanitarian Device Exemption (HDE) submissions;
Biologics License Application (BLA) submissions; and
Investigational New Drug (IND) submissions.

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process”

The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” to support applications to FDA. This guidance document also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations

The scope of this document and accompanying attachments is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. This document specifically covers the use of ISO 10993-1 but also is relevant to other biocompatibility standards (e.g., other parts of the ISO 10993 series of standards, ASTM, ICH, OECD, USP).

Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

The guidance is intended to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with FDA’s informed consent regulations for clinical investigations. This document is structured to first present general guidance on FDA’s regulatory requirements for informed consent and a discussion of the roles of IRBs, clinical investigators, sponsors, and FDA related to informed consent, followed by a series of frequently asked questions.

The term informed consent is mistakenly viewed as synonymous with obtaining a subject’s signature on the consent form; however, obtaining documentation of a subject’s informed consent is only part of the consent process. Informed consent involves providing a prospective subject, or their legally authorized representative (LAR), with adequate information to allow for an informed decision about participation in the clinical investigation prior to enrollment. Informed consent also involves facilitating the prospective subject’s understanding of the information, providing adequate opportunity for the prospective subject to ask questions and to consider whether to participate, obtaining the prospective subject’s voluntary agreement to participate prior to enrollment, and continuing to provide information as the clinical investigation progresses or as the enrolled subject or situation requires

Off-The-Shelf Software Use in Medical Devices

The guidance document is intended to provide information regarding the recommended documentation sponsors should include in a premarket submission for FDA’s evaluation of off the-shelf (OTS) software used in a medical device. The recommendations in this guidance are also intended to facilitate FDA’s premarket review. This guidance describes information that would be typically generated and documented during software development, verification, and validation. The least burdensome approach was applied to identify the minimum amount of information that, based on our experience, would generally be needed to support a premarket submission for a device that uses OTS software.

For the purposes of this guidance, unless otherwise stated, the term premarket submission includes, but is not limited to, premarket notification (510(k)) submission, De Novo classification request, Premarket Approval (PMA) application, Investigational Device Exemption (IDE), or Humanitarian Device Exemption (HDE).

Medical Device User Fee Rates for Fiscal Year 2024

The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.

The US FDA has released its fee schedule for fiscal 2024. Standard PMAs will cost $483,560 next year, while 510(k) fees are set at $21,760.

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations – Premarket Notification (510(k)) Submissions

This guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. This guidance document applies to all HPCPs. These devices are classified under 21 CFR 886.5918 and 21 CFR 886.5928 with the product codes listed in the document.

These labeling recommendations are important because misuse associated with these devices has resulted in serious eye injuries. FDA believes that the labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses. These labeling recommendations are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.

Qualification of Medical Device Development Tools

The purpose of this guidance is to describe the framework for voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. For purposes of this guidance, a submitter is a person, group, consortium, or organization (including the federal government) that takes responsibility for and initiates the MDDT qualification process using the procedures described in this guidance.

This guidance does not discuss the review of MDDTs (also referred to as “tools” in this guidance) that are submitted in individual premarket regulatory submissions for use with a particular medical device, nor does it address the specific evidentiary or performance expectations for the qualification of an individual MDDT submission.

Content of Premarket Submissions for Device Software Functions

The purposes of this document, FDA refers to a software function that meets the definition of a device as a device software function.

This guidance recommends the information to provide in a premarket submission that includes a device software function(s). For the purposes of this guidance, the term premarket submission includes, but is not limited to, premarket notification (510(k)) submission, De Novo classification request, Premarket Approval (PMA) application, Investigational Device Exemption (IDE), Humanitarian Device Exemption (HDE), or Biologics License Application (BLA). Certain devices are subject to premarket review through a BLA under section 351 of the Public Health Service Act.

This guidance does not apply to automated manufacturing and Quality System software or software that is not a device. For further information or to clarify the documentation expectations, please contact the responsible FDA review division.

Generally, the recommendations in this guidance apply to the device constituent part of a combination product18 (such as drug-device and biologic-device combination products) when the device constituent part19 includes a device software function, including combination products assigned to CDER and CBER regulated under drug or biological product market submission types. For more information, contact the FDA review Division that will have the lead review for the combination product.

General Considerations for Animal Studies Intended to Evaluate Medical Devices

This guidance is applicable to animal studies intended to provide evidence of device safety, which may include performance and handling, in premarket submissions to FDA. These types of submissions include investigational device exemption (IDE) applications, premarket approval applications (PMA), premarket notification (510(k)), humanitarian device exemption (HDE) applications, or De Novo classification requests. This guidance is not intended to alter or supersede any device specific final guidance but is intended to augment the recommendations in device-specific guidance.

This guidance also does not apply to basic exploratory studies conducted to determine whether a device has any potential utility or preliminary assessments of physical or chemical characteristics of a device. In addition, this guidance does not apply to, nor changes any regulatory requirements relevant to, animal studies conducted under the Animal Rule.21 Finally, this guidance is not intended to address the regulations and policies of other agencies.

Laser Products – Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 56)-Guidance for Industry and Food and Drug Administration Staff

The guidance describes the Food and Drug Administration’s (FDA) approach regarding manufacturers’ compliance with FDA’s performance standards for laser products. FDA regulates radiation-emitting electronic products, including all types of lasers products. Laser product means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product shall itself be considered a laser product (see 21 CFR 1040.10(b) (21)).

The Agency sets radiation safety product performance standards that must be met by manufacturers in order for laser products to be legally sold in the U.S. market. Laser products may fall under both the definition of a medical device and that of an electronic product, under sections 201(h) and 531(2) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), respectively. Such products are subject to the provisions of the FD&C Act and its implementing regulations that apply to medical devices1 and electronic products.

Medical X-Ray Imaging Devices Conformance with IEC Standards-Guidance for Industry and Food and Drug Administration Staff

This guidance addresses diagnostic x-ray imaging systems and their major components (see 21 CFR 1002.1 and 21 CFR 1020.30(a)(1)). Most diagnostic x-ray imaging systems and their major components are classified as Class I or II devices. And also includes the regulations and product codes for these devices. The guidance does not address radiation therapy products because there are no EPRC performance standards promulgated for these products. These devices are cleared for market through the 510(k) process.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers- Guidance for Industry and Food and Drug Administration Staff

This guidance document provides detailed recommendations for 510(k) submissions for diagnostic ultrasound systems and transducers. In addition to outlining regulatory approaches for certain diagnostic ultrasound devices, this guidance document describes the types of modifications to a diagnostic ultrasound device for which FDA does not intend to enforce the requirement for a new premarket notification (510(k)).

Safety of diagnostic ultrasound technology

Exposure of tissues to intense levels of ultrasound that are well above the levels found in typical diagnostic ultrasound devices can have significant biological effects. Therefore, determinations of substantial equivalence have been made in part by comparing the appropriate acoustic output levels of new devices to those of predicate devices of this type that were on the market prior to May 28, 1976, the date of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act), which are known as “preamendments devices.

Marketing Clearance of Diagnostic Ultrasound Systems and Transducers- Guidance for Industry and Food and Drug Administration Staff

Safety of diagnostic ultrasound technology

Medical Devices; Neurological Devices; Classification of the Digital Therapy Device to Reduce Sleep Disturbance for Psychiatric Conditions

The Food and Drug Administration (FDA) is classifying the digital therapy device to reduce sleep disturbance for psychiatric conditions into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the digital therapy device to reduce sleep disturbance for psychiatric conditions’ classification.

US FDA is taking this action because they have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device and believe this action will also enhance patients’ access to beneficial innovative devices.

Medical Devices; Cardiovascular Devices; Classification of the Hardware and Software for Optical Camera-Based Measurement of Pulse Rate, Heart Rate, Breathing Rate, and/or Respiratory Rate

The Food and Drug Administration (FDA) is classifying the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the hardware and software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate’s classification.

Medical Devices; Orthopedic Devices; Classification of the Resorbable Shoulder Spacer

The Food and Drug Administration (FDA) is classifying the resorbable shoulder spacer into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the resorbable shoulder spacer’s classification.

Medical Devices; Physical Medicine Devices; Classification of the Electroencephalography-Driven Upper Extremity Powered Exerciser

The Food and Drug Administration (FDA) is classifying the electroencephalography (EEG)-driven upper extremity powered exerciser into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the electroencephalography (EEG)-driven upper extremity powered exerciser’s classification.

Medical Devices; Physical Medicine Devices; Classification of the Virtual Reality Behavioral Therapy Device for Pain Relief

The Food and Drug Administration (FDA) is classifying the virtual reality behavioral therapy device for pain relief into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the virtual reality behavioral therapy device for pain relief’s classification.

Medical Devices; Neurological Devices; Classification of the Brain Stimulation Programming Planning Software

The Food and Drug Administration (FDA) is classifying brain stimulation programming planning software into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the brain stimulation programming planning software’s classification.

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