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
