The European Medicines Agency has pre-published a draft guidance document for public consultation Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics. Relevant parties such as notified bodies and manufacturers of companion diagnostics can submit suggestions for improvement until 20 February 2022.
To submit your comments and suggestions for improvements to the draft document, use this template and send to companiondiagnostics.consultation@ema.europa.eu
Related links:
Specific privacy statement for public and targeted consultations
Application form for consultation by a notified body on a companion diagnostic (DOCX/125.09 KB)
Consultation on companion diagnostic - Assessment report template (DOCX/135.81 KB) (new)
Source:
https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices