Consultation procedure for ancillary medicinal substances in medical devices
Regulation EU 2017/45 requires notified bodies to seek an opinion from a competent authority on the quality and safety of medicinal substances incorporated in medical devices that have an action that is ancillary (i.e supports) to the action of the device. The notified body should give due consideration to the scientific opinion when taking its certification decision.
The European Medicines Agency (EMA) is the competent authority for substances derived from human blood or human plasma or that fall under the scope of the centralised procedure. Notified bodies may also consult EMA for other substances e.g. if the Agency has already evaluated a medicine containing the same active substance. For more information on medical devices with ancillary medicinal substances, see Medical devices.
For a new medical device, the notified body acts as the applicant on behalf on device manufacturer in an initial consultation procedure with EMA. It should provide an 'intention to submit' letter, preferably at least six months before it expects to submit the application. Further details are available in the questions and answers (Q&A) and the guidance documents below.
When changes are made to an ancillary substance for which EMA has already given an opinion, in particular to its manufacturing process, the notified body should consult the Agency to confirm that quality and safety are maintained. This is called a post-consultation procedure with EMA.
For further guidance on the procedures, see:
- EMA recommendation on the ancillary substances consultation procedure
- Consultation procedure - Q&A
- Application form - Initial consultation procedure
- Application form - Post-consultation procedure
- Medical Devices Guidance document (MEDDEV)