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MDCG 2024-10 – Clinical evaluation of orphan medical devices – June 2024

25 Jun 2024 | All the News, MDCG, MDCG

Theme Clinical evaluation Target Audience Manufacturers, NB Products concerned Orphan medical devices Documents mentioned MDR (EU) 2017/745 – article 60 Article 35 of the Charter of Fundamental Rights states These are guidelines for manufacturers and notified bodies...

MDCG  2024-7 – Preliminary assessment review (PAR) form template (MDR) – May 2024.

23 May 2024 | MDCG, MDCG

Theme Assessment of notified bodies  Target Audience Designating authority, NB  Products concerned MD Documents mentioned MDR (EU) 2017/745 – article 39 MDCG 2022-13  This guidance document is a form template to be used by the designating authority as part of the...

MDCG  2024-9 – Preliminary re-assessment review template – IVDR (Regulation (EU) 2017/746)  – May 2024

23 May 2024 | MDCG, MDCG

Theme Re-assessment of notified bodies  Target Audience Designating authority, NB  Products concerned IVD Documents mentioned IVDR (EU) 2017/746 article 40(10) MDCG 2022-13  This document is a template form to be used by the designating authority in the context of the...

MDCG  2024-8 – Preliminary assessment review template – IVDR (Regulation (EU) 2017/746) – May 2024

23 May 2024 | MDCG, MDCG

Theme Assessment of notified bodies  Target Audience Designating authority, NB  Products concerned IVD Documents mentioned IVDR (EU) 2017/746 – article 35 MDCG 2022-13  This guidance document is a form template to be used by the designating authority in the context of...

MDCG  2024-6 – Preliminary re-assessment review template – MDR (Regulation (EU) 2017/745)  – May 2024

23 May 2024 | MDCG, MDCG

Theme Re-assessment of notified bodies  Target Audience Designating authority, NB  Products concerned MD Documents mentioned MDR (EU) 2017/745 article 46 MDCG 2022-13  This document provides a template form for use by designating Authorities (NAs) in the reassessment...
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