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Verification of manufactured class D IVDs by notified bodies Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to in accordance with Directive 98/79/EC Summary of safety and performance template Q&A on the interface between Regulation (EU) 536/2014 on clinical trials for medicinal products for human use (CTR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDDĬlarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 Performance study application/notification documents under Regulation (EU) 2017/746 Substantial modification of performance study under Regulation (EU) 2017/746 Regulatory requirements for ventilators and related accessories Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 contextĬonformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 Guidance on regulatory requirements for medical face masks

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How to verify that medical devices and personal protective equipment can be lawfully placed on the EU market and thus purchased and used – also in the COVID-19 context Guidance on state of the art of COVID-19 rapid antibody testsĬOVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19 (available in all EU languages and Arabic, Chinese, Japanese, Russian)Ĭonformity assessment procedures for protective equipment

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 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