New MDCG Guidance documents released

Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
May 27, 2024

On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies.

On May 15^th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies:

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.

Should you want to discuss this more in-depth with one of our consultants, please do not hesitate to contact us.

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