On 18 May 2020, the European Commission published in the Official Journal of the European Communities ‘Implementing Regulation (EU) 2020/666 amending Implementing Regulation (EU) No 920/2013 as regards the renewal of designations and the surveillance and monitoring of notified bodies’. The 920/2013 regulation detailed “a common interpretation of the main elements of the criteria for…

The European Commission has now published the standardisation mandate for the harmonisation of standards under the Medical Device Regulation (MDR, 2017/745) and In Vitro Diagnostics Regulation (IVDR, 2017/746) in the European Standards section of the Commission website. The mandate is titled: ‘M/565 COMMISSION IMPLEMENTING DECISION C(2020) 2532 of 15.5.2020 on a standardisation request to the…

On the 26th May 2020, DIMDI and the Federal Institute for Drugs and Medical Devices (BfArM) will join to become one agency, “to better prepare for the future”, according to the German Federal Minister for Health. Once DIMDI is merged into BfArM, the DIMDI name will no longer be used after 50 years of operation….