25 January 2021 – MedTech Europe has updated the IVDR/MDR implementation tracker.
This is a very helpful document as it shows you the state of EU documents and provides hyperlinks to directly access them. The document has two separate sections - one for published material and another for documents in the pipeline. We hope this structure helps you navigating throughout the document and get to the information you are looking for.
6 January 2021 – Publication of the expert names
The IVDR requires the European Commission to create expert panels to support the scientific assessment and advice in the field of vitro diagnostic medical devices. Amongst others, the panels of experts will provide an opinion on the notified bodies’ assessments of performance evaluation of certain in vitro diagnostic medical devices. The European Commission has published the names of the experts (voir le panel n° 12).
3 December 2020 – European Commission’s EUDAMED database
The European Commission’s EUDAMED database, a critical component of the MDR IVDR, was launched with the actor registration module. At present, economic operators established in the EU or European authorized representatives may register. Economic operators based in Switzerland will NOT be able to register until an agreement between Switzerland and the EU can be reached.
19 November 2020 – Harmonised standards under IVDR
A request for harmonisation of standards was submitted to the European Commission for adoption and submission to the European Committee for Standardization and the European Committee for Electrotechnical Standardization (CEN/CENELEC). Annex II contains a list of 45 existing and 3 new standards with deadlines for their adoption.
18 November 2020 – Guidance on the classification of in vitro diagnostics
The European Commission’s Medical Device Coordination Group (MDCG) has released its much-anticipated guidance on the classification of in vitro diagnostics under the IVDR. The 50-page guidance explains to manufacturers, notified bodies and healthcare providers how IVDs should be classified before they are placed on the EU market.