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Last month, Medtech released the 3rd revision of the clinical evidence requirements under the EU In Vitro Diagnostic Medical Device Regulation 2017/746 (IVDR). This guidance document from Medtech is a collection of questions and answers designed to help manufacturers navigate their performance evaluation obligations under the new IVDR. Medtech – Clinical evidence requirements
On February 14th, 2023, the Medical Device Coordination Group (MDCG) released a Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices (MDCG 2023-03). MDCG 2023-03 Q&A on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices. This document
On March 1st, 2023, Team NB released a new position paper on best practice guidance for the submission of technical documentation under Annex II and Annex III of the European (EU) In Vitro Diagnostic Regulation 2017/746 (IVDR). This best practice guidance document has been developed by members of Team NB
On January 6th, 2023, the European Commission (EC) adopted a proposal to extend the already existing transitional period for legacy devices under the MDR. The goal of this extension is to maintain patients’ access to a wide range of medical devices while ensuring the transition to the new framework under
