Medical Devices – USA, Europe and ROW Regulatory News – July 2024

USA

Medical Device User Fee Rates for Fiscal Year 2025

The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for the fiscal year (FY) 2025. This notice establishes the fee rates for FY 2025, applicable from October 1, 2024, through September 30, 2025. It provides details on how the FY 2025 fees were determined, outlines the payment procedures, and explains how businesses can qualify for reduced small business fees.

Clinical Considerations for Studies of Devices Intended to Treat Opioid Use

The guidance is for pivotal clinical studies on devices treating Opioid Use Disorder (OUD) and supporting marketing submissions. It helps sponsors and investigators design studies ensuring the safety and effectiveness of these devices. While focusing on well-controlled pivotal studies, the recommendations can also apply to other studies generating valid scientific evidence.

EUROPE

MDCG 2020-16 rev.3 Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746

The guidance addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules.

MDCG 2020-16 revision 3 made changes on addition of ‘kit’ definition, Rule 3(a) Revision of examples, Rule 4(a) Revised, Rule 5(c) Revised, Rule 6 Minor revision of example.

Update – MDCG 2021-5 Rev.1 – Guidance on standardization for medical devices

The document aims to provide guidance on various aspects related to standards in the medical devices sector, supporting the requirements outlined in the applicable EU legislation, while considering its specificities.

AUSTRALIA

Essential Principle 13B guidance: Information on how to interpret Essential Principle 13B and how it applies to your device

To supply a medical device in Australia, sponsors or manufacturers must demonstrate compliance with the Essential Principles (EPs) for safety, quality, and performance. There are six general EPs applicable to all devices and nine additional EPs related to design and construction that apply on a case-by-case basis. Essential Principle 13B requires that the current version and build number be accessible and identifiable to users of software-based medical devices, displayed in English (and optionally in other languages). Medical devices in the Australian Register of Therapeutic Goods (ARTG) have transition arrangements to meet EP13B requirements by November 2024.

Regulatory changes for software based medical devices

The guidance outlines changes to software-based medical device regulation that began on February 25, 2021, including transition arrangements for devices needing reclassification or qualifying for exemptions. New applications must follow the new classification rules from this date, with a transition period ending on November 1, 2024. Devices reclassified under the new rules can continue being supplied during this period while applying for inclusion in the ARTG under the new classification. Devices already in the ARTG before February 25, 2021, can continue being supplied without meeting Essential Principle 13B until November 1, 2024.

CANADA

Regulatory enrolment process (REP) 

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to:

• Company
• Dossier and product
• Regulatory activity
• Regulatory transaction

REP consists of web-based templates that capture information in a structured format. This process enables a shift towards a common submission intake across product lines and allows Health Canada to:

• Receive a broader range of regulatory information via the Common Electronic Submission Gateway (CESG)
• Automate the import of regulatory transactions into its repositories

CZECH REPUBLIC

Agenda for registration of persons

Effective 1 July 2024, the agenda for the registration of persons has been transferred from the Department of Registration and Notifications (RAN) to the Department of Systems (SYS). This transfer involves processing notifications in the Information System of Medical Devices (ISZP) related to distributors, service providers, and manufacturers of custom-made devices, as specified in § 23 of Act No. 375/2022 Coll. It also includes fulfilling obligations under the transitional provision of § 74 paragraph 7 of Act No. 375/2022 Coll., concerning the registration of activities of manufacturers, authorized representatives, and importers in the Register of Medical Devices (RZPRO). Additionally, the SYS department handles requests for the allocation of a single registration number for the Federal Republic of Germany in the EUDAMED database.

ITALY

Medical devices and in vitro diagnostic medical devices, new EU provisions

The Regulation amends the provisions on the mandatory use of the European database of medical devices (EUDAMED) for devices compliant with the Regulations and for legacy devices. It also introduces the obligation for manufacturers to provide advance notice of the interruption or cessation of supply of a device that is likely to cause serious harm or pose a risk of serious harm to patients or public health.

MEXICO

Cofepris submits a standard for consultation to guarantee the safety and effectiveness of medical devices

On 26 July, Mexico’s COFEPRIS announced the opening of a comment period on a new scheme for device regulation aimed at adopting internationally used terms and tightening reporting requirements to improve standards. Mexico’s device industry has seen steady growth in recent years, and the draft rule proposes to “allow for the unification of application criteria at a national level harmonized with international guidelines,” according to its preamble. The proposed rule details each regulatory term and acronym and establishes new surveillance protocols for devices. For instance, marketing authorization holders, distributors, and sellers of medical devices would be required to immediately notify Mexico’s health secretary of any adverse events reported to them. The 60-day public comment period will end in late September.

PORTUGAL

Transition period of the European Clinical Trials Regulation No. 536/2014 of 16 April Ends on 30 January 2025

The transition period of the European Clinical Trials Regulation No. 536/2014 of April 16 ends on January 30, 2025. Therefore, if a promoter of clinical trials authorized under Directive No. 2001/20/EC of April 4, and which are expected to take place after January 30, 2025, must act now to transfer them to the Clinical Trials Information System, CTIS.

Regulation (EU) 2024/1860 introducing amendments to Regulations (EU) 2017/745 and (EU) 2017/746

Regulation (EU) 2024/1860 has been published, amending Regulations (EU) 2017/745 and (EU) 2017/746. It addresses the progressive availability of Eudamed, the obligation to provide information in case of supply interruptions or discontinuations, and transitional provisions for certain in vitro diagnostic (IVD) medical devices. This regulation aims to ensure the market availability of essential IVDs for healthcare by giving manufacturers more time to comply with the new rules under Regulation (EU) 2017/746 (IVDR), while maintaining safety and reducing the risk of shortages.

SAUDI ARABIA

Requirements for Clinical Trials of Medical Devices

The document is to specify and clarify the requirements for conducting clinical trials of medical devices within KSA. The document applies to organizations or researchers wishing to conduct clinical investigations of medical devices or clinical performance studies of in vitro diagnostics medical devices within KSA.

SWITZERLAND

Guidance document on Vigilance contact person for medical devices

The document is intended to provide hospitals, particularly the vigilance contact persons for medical devices, with an overview of the development steps a device undergoes before it is placed on the market and its post-market surveillance. It focuses on the contribution made by hospitals to this process, explaining the requirements for the hospital reporting system and the role of the vigilance contact person.

Information sheet on Clinical investigations with medical devices

Information sheet is intended for sponsors of clinical investigations of devices, contract research organizations (CROs), and investigators. It provides guidance on the authorization process, reporting requirements of sponsors, and the surveillance of clinical investigations by the Swiss Agency for Therapeutic Products, Swissmedic.

Information sheet Performance studies with IVD

Information sheet is intended for sponsors of performance studies with IVD, contract research organizations (CROs), and investigators. It provides guidance on the authorization process, reporting requirements of sponsors, and the surveillance by the Swiss Agency for Therapeutic Products, Swissmedic.

UNITED KINGDOM

Update: Guidance on Medical devices: UK approved bodies

The guidance provides list of UK approved bodies and types of medical devices for which the approved body is permitted to issue UKCA certification.