Regulatory Newsletter
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 | 20...
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 Regulation (EU)...
June Newsletter
EU Regulations European Medical Device Nomenclature (EMDN) - Questions and Answers | 15 June 2021 The European Commission (MDCG) published a question and answers article for European Medical Device...
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 position paper on the...
April Newsletter 2021
April Newsletter 2021: EU REGULATIONS Factsheet for Class I - Medical Devices | 28 April Newsletter 2021 European commission published a Factsheet for Class I- Medical Devices based on MDCG 2019-5...