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New MDCG Guidance documents released
- Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager
On May 15th, 2024, the Medical Device Coordination Group (MDCG) released 4 new documents for notified bodies.
![MDCG](https://qbdgroup.com/wp-content/uploads/Image-blogRegulatory-update-website-3.png)
On May 15th, 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.
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