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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- MDCG Position Paper: UDI assignment between manufacturers and distributors
- EMA Questions & answers on Article 31 non-pharmacovigilance referral procedures
- EXTENSION OF THE MDR TRANSITIONAL PERIOD AND REMOVAL OF THE ‘SELL OFF’ PERIODS
- MHRA Updated guidance for the International Recognition Procedure (IRP)
- MDCG 2021-5 Rev. 1 .Guidance on standardisation for medical devices
- Qualification of novel methodologies (QoNM) for medicinal product development . Procedural Guidance to applicants
- FDA Guidance for Drug Development