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EU: MDCG guidance on IVDR codes

The new MDCG 2021-14 contains explanatory information about the codes, which includes the scope of the designation for the notified body.

As part of the consultation procedure in accordance with Article 54 MDR for specific products in Class III and IIb, the EU has published the first scientific report from an expert committee

The EU has published a revised guidance document (MDCG 2021-13), which answers questions regarding EUDAMED registration of actors other than manufacturers, authorised representatives and importers.

The EU has published a number of new MDCG guidance documents.

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.