Timetable for EMA advice to medical device manufacturers

The European Medicines Agency (EMA) has published its timetable concerning the Agency’s procedure for providing advice to medical device manufacturers. This advice procedure, which is based on Article 54 of the Medical Devices Regulation (MDR), is intended to review manufacturers’ intended clinical development strategy and proposals for clinical investigation.

The timetable includes information concerning the date by which final briefing documents must be submitted to the EMA, when the procedure will start, when questions will be provided to manufacturers by the EMA, the dates on which discussion meetings will take place between the EMA and applicants, and the dates on which Advice Letters will be provided by the EMA.