Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed) (Nov 2021)
MDCG – Substantial modification of clinical investigation under Medical Device Regulation (Dec. 2021)
MDCG – Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (Dec. 2021)
Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards electronic instructions for use of medical devices (Dec. 2021)
IMDRF Working group on adverse event terminology Annex A: Medical Device Problem
Progressive roll-out of the In Vitro Diagnostic Medical Devices Regulation (Dec. 2021)
Open discussion during the Project Board Meeting: Essential principles for clinical investigations of medical devices
New Medical Device Regulation. ESC podcast with Prof Alan Fraser and Prof. Thomas Lüscher
New Medical Device Regulations Take Effect in Europe. 2 June 2021, tctMD.
Fraser AG, et al.The need for transparency of clinical evidence for medical devices in Europe. Lancet. 13 July 2018.
IMDRF.Clinical Evaluation. 10 October 2019.
Reckers-Droog V, et al. Challenges with coverage with evidence development schemes for medical devices: a systematic review. Health Policy Technol. June 2020.