The Medical Device Coordination Group (MDCG) released a Device Specific Vigilance Guidance Document (DSVG) to harmonize vigilance reporting and provide guidance for manufacturers of Specific Devices.
Commission Implementing Decision (EU) 2024/815 as regards harmonised standards for “medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products” and “Commission Implementing
The Council of the European Union officially endorsed without any changes the proposal to amend IVDR and MDR
EU Commission proposes IVDR & MDR amendments: Eudamed rollout, supply interruption reporting, extended transitional provisions for certain IVDR devices.
EU Commission published MDR and IVDR language requirement tables for medical device manufacturers, aiding compliance with linguistic regulations across Member States.
EMA released Q&A on biomarker-guided meds, excluding clinical trial approval and CDx conformity. Offers guidance for marketing authorization data generation.
MDCG revises Q&A on importers, distributors’ requirements (MDCG 2021-27 Revision 1), EU Regulations 2017/745 & 2017/746.
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