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MDCG 2022-1Notice to 3rd country manufacturers of SARS-CoV-2 in vitro diagnostic medical devicesJanuary 2022⌄
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MDCG 2021-7Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devicesMay 2021⌄
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MDCG 2021-2Guidance on state of the art of COVID-19 rapid antibody testsMarch 2021⌄
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Guidance documentCOVID-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 )February 2021⌄
COVID-19 TESTS: Q&A on in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19PDF · Unverified extraction previewOfficial source
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Guidance documentConformity assessment procedures for protective equipmentJuly 2020⌄
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Guidance documentHow 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 contextMay 2020⌄
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Guidance documentGuidance on regulatory requirements for medical face masksJune 2020⌄
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Guidance documentGuidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 contextApril 2020⌄
Guidance on medical devices, active implantable medical devices and in vitro diagnostic medical devices in the COVID-19 contextPDF · Unverified extraction previewOfficial source
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Guidance documentConformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19April 2020⌄
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19PDF · Unverified extraction previewOfficial source
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MDCG 2020-9Regulatory requirements for ventilators and related accessoriesApril 2020⌄
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MDCG 2020-17Questions and Answers related to MDCG 2020-4:“Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictions”December 2020⌄
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MDCG 2020-4Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19 quarantine orders and travel restrictionsApril 2020⌄
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