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.
- 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?
with ease.
关于作者
MSc Biomedical Sciences · Business Unit Manager RA IVD & Representative Services
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
Navigate Regulatory Complexity with Confidence
Navigate complex regulatory landscapes with expert guidance across pharmaceuticals, medical devices, and IVD.
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