Tool to retrieve public information on medical devices

Protocol for a systematic review

Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021

MDCG – Substantial modification of clinical investigation under Medical Device Regulation (Dec. 2021)

MDCG – Q&A on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746

Commission Implementing Regulation (EU) 2021/2226 of 14 December 2021 as regards electronic instructions for use of medical devices

FAQ on the European Medical Device Nomenclature (EMDN)

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)

Implementation of the new EU IVD Regulation – urgent initiatives are needed to avert impending crisis.