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MDCG 2024-7 rev.1 MDCG 2021-15/MDCG 2024-7 AnnexPreliminary assessment review (PAR) form template (MDR) Annex to Application Form & PAR Template MDR (List of documents)January 2025⌄
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MDCG 2024-8 rev.1 MDCG 2021-16/MDCG 2024-8 AnnexPreliminary assessment review (PAR) form template (IVDR) Annex to Application Form & PAR Template IVDR (List of documents)January 2025⌄
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MDCG 2024-9Preliminary re-assessment review (PRAR) form template (IVDR)May 2024⌄
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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 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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MDCG 2020-11Guidance on the renewal of designation and monitoring of notified bodies under Directives 90/385/EEC and 93/42/EEC to be performed in accordance with Commission Implementing Regulation (EU) 2020/666 amending Commission Implementing Regulation (EU) 920/2013May 2020⌄
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