The second amendment to the MDR/IVDR standardisation request M/575 has been adopted on 27 May 2024 as “COMMISSION IMPLEMENTING DECISION amending Implementing Decision C(2021) 2406 on a standardisation request to the European Committee for Standardization and the European Committee for Electrotechnical Standardization as regards medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746 of the European Parliament and of the Council, as regards the scope and validity of the request and the deadlines for the joint final report and for the adoption of certain harmonised standards, certain general requirements and the requirements for certain specific standards (C(2024)3371)”.
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- The new CTIS Sponsor Handbook (v6.2, March 2026)
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