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EU - Harmonisation of additional standards with MDR and IVDR
The EU commission has harmonised additional standards with MDR and IVDR by issuing implementing decisions. Links to the implementing decisions and to consolidated summaries of standards harmonised with MDR and IVDR are available on the respecitve EU website.
The EU-Commission has published their proposal to modify the Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR). The proposal is part of a larger package with proposals for regulatory changes in the health sector.
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EU - Update of the MDCG vigilance Q&A guidance
The MDCG has updated the guidance document MDCG 2023-3 and published it in revision 1. The updated version expands the scope to cover MDR and IVDR, includes new questions and additional examples.
EU – Q&A document on reporting of interruption or discontinuation of supply of certain devices
The EU-Commission has published a Q&A document addressing the additional reporting requirements of interruption or discontinuation of supply of certain devices introduced in Article 10a qith the latest MDR and IVDR changes. The document supports manufactures in the interpretation of the requirements. A referenced “Manufacturer Information Form” that is planned for the reporting is currently not yet available.
EU - MDCG updates at year's end
In December the MDCG published new and updated guidance documents. MDCG 2025-9 on procedures for "breakthrough devices" and MDCG 2025-10 on post-market surveillance (PMS) have been added. MDCG 2025-7 on the master UDI-DI has been updated and is now available in revision 1. In addition the EU updated the "PMSV reporting forms" page, updating the helptext to the reporting form but not the form itself according to the changelog.
Within their activities announced for the end of 2025 the EU has started an initiative aimed at harmonising the work of notified bodies.
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EU - First Eudamed modules declared functional
The EU has published Commission Decision (EU) 2025/2371 in the EU Official Journal that declares the first for modules of Eudamed as functional. This triggers the start of a 6 month transition period for manufacturers until the mandatory use of the modules that starts on 2026-05-28.
The EU also published an updated Roadmap that shows that the vigilance module will again be delayed compared to previous versions of the document.
EU - New version of the borderline manual published
The EU has published a new version of the Borderline Manual. The document covers questions on differentiation between medical devices, IVDs and other products as well as classification of medical devices and IVDs. In the new version several examples on the qualification as a device were added.