Team NB Position Paper: IVDR Certification Process

New Team NB Guidance Clarifies IVDR Certification Process for In-Vitro Diagnostic Devices

In April, Team-NB published an IVDR Certification Process consensus document, outlining the pre-application and application procedures for manufacturers seeking Notified Body (NB) certification of in-vitro medical devices. This guidance aligns with the requirements of the In-Vitro Medical Devices Regulation [IVDR] (EU) 2017/746, as detailed in Annex VII §4.2 and §4.3. It applies to both legacy devices (pursuant to Article 110) transitioning to IVDR, and new devices entering the market that have not been previously certified under the Directives. By outlining a comprehensive description of the application process, which includes the steps involved and the essential information and data required from manufacturers (outlined in Appendix A), the guidance aims to foster a shared understanding and reduce the number of incomplete submissions received by NBs.

Additional information on the NB IVDR certification process can be found here.

For further information, contact us.

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