Medical Devices Regulation: additional information about the procedure for medical devices

The date of application of the Medical Devices Regulation (MDR, EU 2017/745) is getting closer. In order to estimate the workload for the Medicines Evaluation Board properly, the logistics relating to the submission of procedures has been adapted. From now on a Consultation Procedure (CP) number must be requested prior to a new consultation procedure or transfer. Notified bodies are also being asked to announce a reconsultation 3 months prior to the submission.

Request CP number prior to the first consultation procedure, or in the event of a transfer

The notified body must request a CP number by no later than 3 months prior to the submission of a consultation procedure or transfer. The notified body is also asked to indicate in which month the submission will take place.

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