Team-NB PP: “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices Regulation”

This PP has been prepared by all the Team-NB IVD active members and approved by all of the IVD NBs voters. Team-NB PositionPaper-BPG-IVDR-V1-20230225.docx  

2023-03-01T09:58:19+01:00

Commission proposal for amending Regulations as regards the transitional provisions for MDs and IVDs.

The Team-NB members are happy to learn that on 16th February 2023, European Parliament has voted with overwhelming majority to accept it. The formal adoption and subsequent publication in the Official Journal is now expected soon. The proposal will allow safe medical devices to remain available to patients and healthcare professionals. Team-NB members remain fully [...]

2023-02-17T08:53:29+01:00

Team-NB statement

The Team-NB members welcome the Commission proposal for amending Regulations as regards the transitional provisions for MDs and IVDs. The adoption of this proposal by European Parliament and Council will allow safe medical devices to remain available to patients and healthcare professionals. Team-NB members remain fully involved in all necessary activities with EU Authorities and [...]

2023-01-11T11:13:07+01:00
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