New documents published by the European Commission! Posted on March 20, 2020 By mdss We will comment based on the feedback and questions MDSS may receive. State of play of joint assessments of Notified Bodies in the medical device sector.pdf MDCG 2020-1 Guidance on Clinical Evaluation (MDR) : Performance Evaluation (IVDR) of Medical Device Software.pdf MDCG 2020-2 Class I Transitional provisions under Article 120 (3 and 4) – (MDR).pdf Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.pdf MDCG 2019-8 v2 – Guidance document – Implant Card relating to the application of Article 18 Regulation (EU) 2017:745 of the European Parliament and of the Council of 5 April 2017 on medical devices.pdf MDCG 2018-1 v3 Guidance on BASIC UDI-DI and changes to UDI-DI.pdf Joint Implementation:preparedness plan on the new Medical Devices Regulation 2017:745 (MDR).pdf Planned meetings of Medical Device Coordination Group (MDCG) and subgroups in 2020.pdf
