EMA Guidance Companion Diagnostics!

On June 17th, 2022, the European Medicines Agency (EMA) released its guidance on procedural aspects to facilitate the consultation procedure to the EMA by notified bodies on companion diagnostics, as per Article 48(3), (4), (7) and (8) of the IVDR.

This guidance document is intended to provide the relevant parties, in particular notified bodies, device manufacturers and medicinal product applicants, with information about procedural aspects of the consultation procedure to the EMA by a notified body on a companion diagnostic (CDx).

The document gives practical guidance on what should be considered for:

  • The initial consultation procedure to the EMA by notified bodies on a companion diagnostic medical device and,
  • A follow-up consultation in case of changes affecting the performance and/or the intended use and/or the suitability of the device in relation to the medicinal product(s) concerned for which the notified body considers there is a need for a supplement to the EU technical documentation assessment certificate or the initial EU type-examination certificate and hence a further consultation with the EMA.

What does this mean to you?

If you manufacture companion diagnostics this is a valuable document to better understand the procedure to be followed by notified bodies seeking an initial consultation on a CDx, and a follow-up consultation in case of changes affecting the performance and/or the intended use and/or the suitability of the CDx. It is complemented by an updated Q&A document from EMA (Questions & Answers – Practical arrangements on the companion diagnostics consultation procedure to the European Medicines Agency by notified bodies) that offers more insight on the practical arrangements around the consultation procedure.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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