Latest news
EU - Q&A document on the gradual roll-out of EUDAMED
The EU has published the third and final Q&A document on the latest changes in MDR and IVDR, addressing questions on the gradual roll-out of EUDAMED.
EU - form for reporting of interruption or discontinuation of supply
On December 6 the MDCG published MDCG 2024-16 and an associated Annex that contain the form for reporting according to Article 10a of MDR and IVDR and an table in case more than one device (model) is affected. The respective Q&A document has not yet been updated at this time.
Manufacturers should consider this form when integrating the requirements of Article 10a into their quality management system.
EU - New MDCG guidance documents
The MDCG published two new guidance documents in November.
MDCG 2024-14 covers the implementation of the Master UDI-DI solution for contact lenses. MDCG 2024-15 determines how clinical investigation reports and their summaries will be published in the absence of the respective EUDAMED module.
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 – New and updated MDCG guidance documents
The MDCG has published one new and two revised guidance documents.
The new guidance MDCG 2024-13 addresses the regulatory status of ethylene oxide, especially the delineation between medical device and biocide. Guidance MDCG 2022-5 on borderline cases between medical device and medicinal product is now available in revision one, with the added case of products specifically intended for cleaning, disinfection and sterillisation of medical devices. Already in mid-October the MDCG updated guidance MDCG 2021-25 on the application of MDR requirements to “legacy deivices”. In Revision 1 the document was re-structured and substantially changed, taking into account the changes to the MDR.
EU - Updates to the list of harmonised standards for MDR and IVDR
On 2024-10-08 the EU published amendments with harmonised standards for Regulation (EU) 2017/745 (MDR) and (EU) 2017/746 (IVDR) in the official journal (implementing decision (EU) 2024/2631 and (EU) 2024/2625).. The number of harmonised standards increases by one for the MDR (to now 25) and by two for the IVDR (to now 15).
Consolidated summary lists of the harmonised standards are published here for the MDR and hier for the IVDR.
EU - New MDCG Guidance Documents
The MDCG has published two new guidance documents: MDCG 2024-11 covers the qualification of in vitro diagnostic medical devices. MDCG 2024-12 provides information for Notified Bodies with respect to corrective and preventive action during the joint assessment by authorities. Back in semptember MDCG 2021-4 Rev.1 was published, an update on the application of transitional provisions for certification of class D IVDs .