MDCG Updates: Status of MIR, FSCA, Trend Report Forms & Guidance, and MDCG 2023-3 Revised
8 January 2025
UK MHRA Publishes Guidance on the New Post-Market Surveillance (PMS) Regulation
21 January 2025Overview
Article 10a, newly introduced under Regulation (EU) 2024/1860, goes into effect today.
MDR/IVDR Article 10a requires that manufacturers notify relevant parties when an interruption or discontinuation is reasonably foreseeable, and could result in “harm or a risk of serious harm to patients or public health in one or more Member States”.
Last month the EU Commission published the Manufacturer Information Form in MDCG 2024-16 (Revision 0; December 2024). Further, the Commission published guidance on Article 10a in its Q&A on the Obligation to Inform of Device Interruption or Discontinuation (Revision 1; December 2024).
Switzerland
Swissmedic announced 1 January 2025, that Article 10a has not been incorporated into its recent legislative amendment.
“The new notification obligation according to Article 10a EU-MDR and EU-IVDR, under which the manufacturer must provide notification of interruption or discontinuation of the supply of certain medical devices is not part of this revision of the Swiss ordinances.”
United Kingdom
From a medical device regulatory standpoint, the four UK countries are divided into two territories:
- Great Britain (England, Scotland, Wales): subject to the UK MDR 2002 requirements. Article 10a does not go into effect in Great Britain.
- Northern Ireland: due to Brexit negotiations, it remains subject to the MDR/IVDR. Article 10a does go into effect starting 10 January 2025.
Link to Procedure Template
Casus is making available a free, word format procedure template for download. The purpose of the procedure is to establish the process used by a manufacturer to inform the required parties of a device supply interruption or discontinuation, when applicable.
To access the document, please visit: MDR/IVDR Article 10a Procedure Template
