![]() ![]() ![]() 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 Guidance on exemptions from the requirements to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on ‘sufficient levels of access’ to data needed to justify claims of equivalenceĬommission Guidance on the content and structure of the summary of the clinical investigation report ![]()
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