Summary
Team-NB has published an updated version of the consensus document on the MDR certification process, describing the pre-application and application phases as well as subsequent activities. The document aims to harmonize the conformity assessment process and will serve as a foundation for the EU DIGICAP project.
Practical Impact
High priority for manufacturers undergoing initial MDR certification, Notified Body (NB) transfer, or renewal. It is recommended to compare your application package checklist with Team-NB’s expectations to ensure its completeness.
Summary
Team-NB has announced the adoption of a document regarding the IVDR Application and Appropriate Surveillance Transfer Agreement. The update aims to support transfer processes between Notified Bodies and the management of appropriate surveillance for IVD devices.
Practical Impact
Relevant for IVD manufacturers who intend to change their Notified Body, hold legacy certificates, or are in the process of transitioning to the IVDR.
Summary
Team-NB has published a position paper on initiatives to support micro and small enterprises. The document highlights that a very significant proportion of manufacturers are SMEs and that many companies depend on predictable and timely market access under the MDR/IVDR.
Practical Impact
This document is not immediately prescriptive but is useful for SMEs in the certification planning phase. It should be monitored for any concrete initiatives or harmonized tools.
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