The Medical Device Coordination Group (MDCG) has issued this September 2022 new guidance on the activities to be performed by the notified bodies as part of Article 110.3 IVDR. The guidance is also relevant for manufacturers of IVD legacy devices to be aware of the expectations when it comes to the verification of their documentation by a notified body in the transitional period.
Firstly, the MDCG indicates that the notified bodies shall continue surveillance activities under the IVDD. Additionally, they need to take into account the new requirements, which are namely the following:
- Contractual . . .
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