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On May 24th, 2023, the European Commission released a new template for Notified Bodies. This form is to be used as confirmation letter on the status of a formal application, written agreement, and appropriate surveillance in the framework of Regulation (EU) 2023/607 amending Regulation (EU) 2017/745 (MDR) and Regulation (EU)
On May 12th, 2023, the Medical Device Coordination Group (MDCG) released the first revision on the 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. (MDCG 2020-03 Revision 1). MDCG 2020-03 Rev. 1
On May 12th, 2023, the European Commission released a guidance, in accordance with Article 77(6) of Regulation (EU) 2017/745 on medical devices (MDR), for the content and structure of the summary of the clinical investigation report. This guidance aims to ensure that the summary of the clinical investigation report presents
On April 27th, 2023, the UK Government published a draft amendment to the UK Medical Device Regulations 2002 which is the first statutory instrument released in the process towards a new regulatory framework. This future regulatory framework will introduce a substantial reform of the current legislation for medical devices (The
