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Medical Devices Newsletter
Medical Devices Newsletter:
EU:
May 28, 2020:
- MDCG 2020-11: Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013 – Link
May 19, 2020:
- EU-Commission: Guidelines on the adoption of union-wide derogations for medical devices in accordance with article 59 of regulation MDR (EU) 2017/745 – Link
May 14, 2020:
- MDR EU 2017/745 consolidated text: MDR consolidated text (including corrigendum 1 and 2 + postponement until May 2021) – Link
May 13, 2020:
April 24, 2020:
- BREAKING NEWS: MDR officially postponed until May 26, 2021. Check the published amendment – EN / DE / FR / IT / ES
- MDCG 2020-8: Post-market clinical follow-up (PMCF) Evaluation Report Template. A guide for manufacturers and notified bodies – Link
- MDCG 2020-7: Post-market clinical follow-up (PMCF) Plan Template. A guide for manufacturers and notified bodies – Link
- MDCG 2020-6: Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC. A guide for manufacturers and notified bodies – Link
- MDCG 2020-5: Clinical Evaluation – Equivalence. A guide for manufacturers and notified bodies – Link
March 17, 2020:
- MDCG 2020-3: Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD – Link
- MDCG 2020-2: Class l Transitional provisions under article 120 (3 and 4) – Link
- MDCG 2020-1: Guidance on Clinical Evaluation (MDR) / Performance Evaluation (IVDR) of Medical Device Software – Link