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The EU has published five additional guidance documents: Four on Regulation 2017/745 (MDR) and one on requirements for ventilators and accessories.
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EU: Additional notified bodies for the MDR
The EU has announced another body for Regulation 2017/745 (MDR) – mdc medical device certification GmbH. There are now 13 notified bodies available.
EU: Postponement of the MDR accepted by the EU Parliament
The proposed postponement of the date of application of Regulation 2017/745 (MDR) has been accepted by the EU Parliament with a clear majority (press release available here). The proposal corresponds to the most recently corrected version from the Council (text available here). The proposal must still pass through the additional EU legislation process and be published in the Official Journal of the EU before it comes into force.
EU: Team-NB publishes a position paper on combination products
Team NB has published a position paper that deals with the opinion of a notified body for the proportion of the medical device that is made up of combination products regulated as medicinal products, which was introduced into the Medicinal Products Directive by Article 117. The position paper provides details regarding the required documentation and the role of the notified body in the procedure.
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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