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EU: Council publishes corrected proposal regarding the postponement of the MDR
The Council of the EU has published a corrected version of the proposal regarding the start date of applicability of the MDR. The new version now also makes changes to Article 120(3), which are required for more consistent implementation of the postponement.
The MDCG has published two new documents in the form of MDCG 2019-3 rev 1 and MDCG 2020-4.
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EU: Commission publishes proposal regarding the postponement of the MDR
The EU Commission has issued a press statement and the corresponding text relating to its proposal for a postponement of the MDR. The proposal must still be accepted by the EU Parliament and the Council in an accelerated process.
In a press conference and an announcement, the EU has announced that it is working on a proposal to postpone the date of application of Regulation (EU) 2017/745 (MDR) by a year.
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The EU has used implementing decisions to update the lists of harmonised standards relating to Directives 93/42/EEC (medical devices), 90/385/EEC (active implants) and 98/79/EC (in-vitro diagnostics).
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EU: Additional notified body for the MDR
Another notified body for Regulation (EU) 2017/745 (MDR) has been entered into the Nando database – the Hungarian organisation CE Certiso Orvos- és Kórháztechnikai Ellenőrző és Tanúsító Kft. This brings the total number of notified bodies for the MDR to twelve.
EU: Two new guidance documents published
The MDCG has published two new guidance documents. MDCG 2020-1 deals with clinical evaluation and performance evaluation for software in particular. MDCG 2020-2 contains information about medical devices in Class I, which are subject to the amended transitional provisions of Article 120 (3/4).
The MDCG has updated two of its guidance documents: Version 3 of MDCG 2018-1 on the basic UDI ID is now available; version 2 of MDCG 2019-8 on implant cards is now available.
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