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.
The notified body can request the CP number (with a reference to the active ingredient and application of the medical device) using the contact form. You can do this by selecting Industry/Trade > Human medicinal products > Medical device / consultation. The CP number will be allocated if it is expected that the procedure can be processed within a certain timeslot. When a CP number is allocated to a medical device, the same CP number will be used for follow-up procedures, such as a reconsultation and/or variations.
Reconsultation
During the consultation the quality, safety and usefulness of the integral substance must be assessed, with the assessment under the MDR being taken into account. It is also requested that notification be given 3 months prior to the submission that a reconsultation is going to be submitted. If a notified body foresees that a reconsultation will take place for several medical devices, a request should be submitted for a pipeline meeting.
Variations
As regards submitting details for a variation, the documentation must be submitted in accordance with, or in line with, the EC/1234/2008 variation regulation for medicinal products. If the notified body has not received any validation comments within two weeks after submission, the procedure will start automatically. The procedure consists of a round of 40 days and, if necessary, a second round of 20 days (excluding clock stop) from the moment that the MDR comes into effect. The same classification is applied to variations as to medicinal products.
