2018 yearly calendar template microsoft word

2018 yearly calendar template microsoft word how to#

2018 yearly calendar template microsoft word how to#

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