MDCG: Notified Bodies and Use of Previous Assessments
The Medical Device Coordination Group (MDCG) has updated its questions and answers document on requirements relating to notified bodies to explain how notified bodies can use previous assessments to avoid unnecessary duplication of work.
During the structured dialogue, manufacturers and notified bodies should agree in the pre-application phase on reusing evidence from previous applications, provided it still meets the “state of the art.” Manufacturers should highlight changes in technical documentation for clarity.
Notified bodies should (partially) rely on prior assessments if:
- Assessment requirements remain unchanged,
- Qualified personnel conducted the assessments,
- Reporting requirements in Annex VII, Section 4.6, are met with ensured traceability.
Reports should specify reused assessment parts and maintain traceability.
Source:
MDCG: Questions and answers: Requirements relating to notified bodies, Revision 5 - February 2025
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