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 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 2022-13 rev.1Designation, re-assessment and notification of conformity assessment bodies and notified bodiesJune 2024⌄
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MDCG 2024-12 MDCG 2024-12 Annex I Form MDCG 2024-12 Annex II FormCorrective and preventive action (CAPA) plan assessment: guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teamsAnnex I: Template CAPA plan and assessment thereonAnnex II: Template JAT review of the CAPA and the DA's opinionOctober 2024⌄
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MDCG 2024-12 Annex I FormDOCX · Unverified extraction previewOfficial source
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MDCG 2024-12 Annex II FormDOCX · Unverified extraction previewOfficial source
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MDCG 2021-18Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)July 2021⌄
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MDCG 2021-17Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)July 2021⌄
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MDCG 2021-16 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the in vitro diagnostic devices regulation (IVDR)Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
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MDCG 2021-15 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexApplication form to be submitted by a conformity assessment body when applying for designation as notified body under the medical devices regulation (MDR)Annex to Application Form & PAR Template MDR (List of documents)January 2025⌄
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NBOG BPG 2017-2Best practice guidance on the information required for personnel involved in conformity assessmentFebruary 2018⌄
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