New MDCG Guidance Documents Released: Key Updates and Insights
New MDCG Guidance Documents Released: Key Updates and Insights
Monday, 27 May 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies.
On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies:
- MDCG 2024-6 preliminary re-assessment review (PRAR) template under Regulation (EU) MDR 2017/745
- MDCG 2024-7 preliminary assessment review (PAR) template under Regulation (EU) MDR 2017/745
- MDCG 2024-8 preliminary re-assessment review (PAR) template under Regulation (EU) IVDR 2017/746
- MDCG 2024-9 preliminary re-assessment review (PRAR) template under Regulation (EU) IVDR 2017/746
These form will be used to document the Designating Authorities (DA) review of the Notified Bodies documentation for (re-)assessment.
What does this mean to you?
MDCG 2024-6/7/8 and 9 are of relevance for the designation of Notified Bodies under MDR and IVDR.
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MDCG revises Q&A on importers, distributors' requirements (MDCG 2021-27 Revision 1), EU Regulations...
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The Medical Device Coordination Group (MDCG) released a procedure for the updates of the European...
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On November 11th, 2024, the Medical Device Coordination Group (MDCG) released its first revision...
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