![]() Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices Guidance on performance evaluation of SARS-CoV-2 in vitro diagnostic medical devices Summary of safety and clinical performance Guidance on clinical evaluation – Equivalence Guidance on sufficient clinical evidence for legacy devicesīackground note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluation ![]() ![]() Guidance on PMCF evaluation report template Guidance on safety reporting in clinical investigationsĪppendix: Clinical investigation summary safety report form Regulation (EU) 2017/745 – Questions & Answers regarding clinical investigationĬlinical evaluation assessment report template Instructions for generating CIV-ID for MDR Clinical InvestigationsĬlinical investigation application/notification documents Substantial modification of clinical investigation under Medical Device Regulation Commission Guidance on the content and structure of the summary of the clinical investigation report
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