Paul-Ehrlich-Institut

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Per­for­mance Stud­ies with In Vit­ro Companion Di­ag­nos­tics (CDx)

In vitro diagnostic medical devices that

  • are developed as companion diagnostics (CDx)
  • are to be used interventionally in the context of a clinical drug trial (e.g. for patient selection) and
  • are not CE marked for their intended use,

require authorisation as of 26 May 2022.

This "authorisation of a CDx performance study" includes a sequential evaluation by an ethics committee and the higher federal authority responsible for the medicinal product.

In the case of co-development, the application for authorisation of the CDx performance study ideally takes place at the same time as the application for authorisation of the associated clinical drug trial of the medicinal product.

Please submit initial submissions and amendments for the authorisation and notification of CDx performance studies via the German Medical Device Information and Database System (DMIDS). There you will also find information about the documents that must be provided for the evaluation.

Deadlines for the initial application for authorisation of a performance study

Legal basis: art. 66 para. 7(b) of the IVDR and section 31a para. 2 of the MPDG

Legal basis: art. 66 para. 7(b) of the IVDR and section31a para. 2 of the MPDG (Source: Paul-Ehrlich-Institut)

Contact

Innovation Office
Phone: +49 6103 772772
Email: cdx@pei.de

Updated: 10.06.2022