Monthly Newsletter

April Newsletter

EU REGULATIONS Factsheet for Class I – Medical Devices | 28 April 2021 European commission published a Factsheet for Class I- Medical Devices based on…
Read more

May Newsletter

EU REGULATIONS MDCG Position Paper on the Implementation of UDI requirements for contact lenses, spectacle frames, spectacle lenses & ready readers| 27 May 2021 The…
Read more

June Newsletter

EU Regulations European Medical Device Nomenclature (EMDN) – Questions and Answers | 15 June 2021 European commission (MDCG) published a question and answers article for…
Read more

July Newsletter

EU REGULATIONS MDCG 2021-23 – Guidance for notified bodies, distributors, and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and…
Read more

August Newsletter

EU REGULATIONS Guidance for notified bodies, distributors and importers on certification activities in accordance with Article 16(4) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746…
Read more

September Newsletter

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation…
Read more