Medical Devices-USA/Europe Regulatory News-September 2023

USA (FDA)

Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors

The FDA has released guidance designed to support institutional review boards (IRBs), clinical investigators, and sponsors in meeting the agency’s requirements for informed consent in clinical investigations. The document outlines core regulatory expectations, clarifies the responsibilities of relevant parties, and provides answers to frequently asked questions. 

The FDA emphasizes that informed consent is more than obtaining a signature. It is an ongoing process in which potential participants—or their legally authorized representatives—receive sufficient information, are given the chance to ask questions, and voluntarily agree to take part. Investigators must continue to offer updated information throughout the study as needed.

Use of Off‑The‑Shelf (OTS) Software in Medical Devices

This guidance describes the documentation FDA recommends including in premarket submissions for medical devices containing off‑the‑shelf (OTS) software. The intent is to streamline FDA review and outline the minimum information typically generated during software development, verification, and validation. 

The term “premarket submission” includes 510(k) notifications, De Novo requests, PMA applications, IDE submissions, and HDE applications unless otherwise stated.

EUROPE

MDR and IVDR Communication Survey

An online survey has been launched to gather insight into stakeholders’ information needs related to the MDR and IVDR. The goal is to understand how the regulatory changes are affecting stakeholders and identify challenges they face during the transition period.

Flowchart on MDR Transitional Provisions

A new flowchart has been published to help manufacturers and other actors determine whether their device qualifies for the extended transitional period under Article 120 of Regulation (EU) 2017/745 (MDR), as amended by Regulation 2023/607. The tool helps determine eligibility, required conditions, and associated deadlines. Users should consult the MDR text and corresponding Q&A for full legal clarity.

Czech Republic (NISZP)

Information Sheet for Non‑EU/EEA Authorities

Manufacturers outside the EU intending to market devices in the EU must understand the timelines and obligations under MDR and IVDR. During the transition period, legacy Directive‑compliant devices and Regulation‑compliant devices will coexist. This is especially important for third countries that rely on CE marking for market entry.

Latvia (ZVA)

New Medical Device Regulations Implemented

On 23 August 2023, Latvia introduced Cabinet of Ministers Regulation No. 461, aligning national requirements with MDR (EU) 2017/745. The previous 2017 regulations on registration, conformity assessment, distribution, and supervision are now replaced.

Rules for Clinical Studies and IVD Performance Studies

Also effective 23 August 2023, Regulation No. 455 establishes procedures for clinical studies involving medical devices and performance studies for IVDs. These rules implement obligations under MDR 2017/745 and IVDR 2017/746 and replace the earlier 2010 clinical research procedures.

Poland (URPL)

Notice on Provision of IVD Devices to Lay Users

Poland clarified restrictions under national law implementing IVDR (EU) 2017/746. Non‑self‑testing IVD devices, except sample containers or general laboratory products, may not be supplied to laypersons. Violations may result in fines up to PLN 250,000. 

Only IVD devices explicitly intended for self‑testing and certified by a notified body—with proper CE marking, notified body number, and labeling in Polish—may be provided to non‑professional users.

Slovakia (SÚKL)

Issuing Free Sale Certificates (FSC)

As of 1 August 2023, SÚKL may once again issue FSCs for medical device and IVD manufacturers or authorized representatives based in Slovakia, following amendments to Act 362/2011.

Temporary Amendments to Act 362/2011

The amendments define requirements for clinical testing and performance studies, as well as rules for handling medicines and devices during crisis situations. They also clarify definitions related to placing medical devices on the market.

Switzerland (Swissmedic)

Swissdamed – Swiss Database on Medical Devices

Swissmedic is developing Swissdamed, an IT platform for managing medical device and IVD regulatory requirements. The system will feature:

• ACT module for company and economic operator registration (available early 2024) 
• Public search portal (early 2024) 
• UDI module for device registration (from summer 2024) 

Modules will be launched in phases.

United Kingdom (MHRA)

Three New UK Approved Bodies

The MHRA has designated three additional Approved Bodies, significantly increasing the UK’s capacity to certify medical devices. Organizations undergo rigorous assessment before designation and are continuously monitored through audits.

MORE Platform – User Guide Updates

The MHRA has updated its guidance for users submitting device‑related incident reports via the MORE platform, including updated screenshots and instructions for draft reports.

Clinical Investigation Notification Guidance

Updated guidance explains how to notify MHRA before conducting a clinical investigation. Devices bearing UKCA/CE/CE UKNI marks for their intended purpose do not require prior notification. New details on applicable fees have been added.

UK Approved Bodies – Scope Updates

The UK has published updated scope information for Intertek Medical Notified Body UK Ltd.

Exporting Medical Devices

The MHRA provides Certificates of Free Sale (CFS) for medical devices exported outside the UK. Guidance has been updated, and applicants should confirm import requirements for destination countries.

Device Registration Requirements

Manufacturers placing devices on the Great Britain or Northern Ireland market must comply with MHRA registration rules. GB manufacturers must appoint an EU or NI Authorized Representative to sell devices in Northern Ireland. Updated account management and registration guides have been published.

Vigilance Guidance for Manufacturers

Manufacturers must report UK adverse incidents and implement corrective actions as needed. Updates reflect recent changes to the MORE portal and reinforce obligations under the UK medical device vigilance system.

CE Marking Recognition

The UK has extended acceptance of CE‑marked devices on the Great Britain market. 

• MDD/AIMDD devices may be placed on the market until certificate expiry or 30 June 2028. 
• IVDD devices may be placed until certificate expiry or 30 June 2030. 
• MDR/IVDR‑compliant devices may be placed until 30 June 2030.

Ireland (HPRA)

Certificates of Free Sale Under Regulation 2023/607

Manufacturers requesting a CFS for devices qualifying under Regulation 2023/607 must submit the revised HPRA application form, including declaration of conformity, self‑declaration, proof of payment, device schedule, and confirmation of manufacturing site if needed. These certificates will carry a three‑year validity period.