EU: Draft of an implementing regulation for EUDAMED
The EU has published a draft of an implementing regulation for EUDAMED for public comment. Comments can be submitted until 22nd June 2021.
EU: Plan for preparation for the IVDR published
The EU has published an "implementation plan" that sets out further steps in the preparation for the implementation of the IVDR, which will come into force in May 2022.
IMDRF: Updated lists of terminology for incidents
The IMDRF has updated Annex A–G with terminology for incident reporting; this can be found on the IMDRF documents page. The corresponding codes are used in the new EU report form. The codes can also be found in the corresponding help texts, but only in the version valid as of September 2019 (i.e. without Annex G).
EU: Draft of a Commission implementing regulation on electronic instructions for use for medical devices
The EU has published the draft of an implementing regulation, which is intended to set out new rules for electronic instructions for use for medical devices under the MDR. It will replace the previous regulation on this topic ((EU) 207/2012). The deadline for public comments expired on 25th May 2021. The regulation is intended to be adopted in the second half of 2021.
EU: First version of EMDN nomenclature available
The EU published the first version of EMDN nomenclature (1.0.0) online. Suggestions for the English translations of the Italian terms can be submitted until 4th June 2021.
EU: UDI helpdesk available
The EU has made the UDI helpdesk available; this will provide information for actors who require support regarding the implementation of UDI obligations. Answers to frequently asked questions are available and users can submit their own questions. The site is currently available in English, Spanish, French and German.
EU: New MDCG position paper on UDIs for contact lenses, spectacle frames, spectacle lenses and ready readers
The MDCG has published position paper MDCG 2021-9, which is intended to clarify the UDI requirements for contact lenses, spectacle frames, spectacle lenses and ready readers. This document expands on the existing, available position paper on UDI assignment for spectacle lenses and ready readers dated December 2020 (MDCG 2020-18).
EU: New MDCG guidance on documents for clinical investigation applications in accordance with the MDR
The MDCG has published guidance document MDCG 2021-8, which contains specifications for the required application documents for clinical investigations in accordance with the MDR. This step was necessary because it is currently not yet possible to submit an application via EUDAMED as actually intended.