The European Medicines Agency has updated its 2015 Question and Answer guidance document on the combination product consultation procedure to align its content with the requirements of the Medical Device Regulation (MDR, 2017/745).
The document has the catchy title of ‘Questions & Answers on the consultation procedure to the European Medicines Agency by notified bodies on an ancillary medicinal substance or an ancillary human blood derivative incorporated in a medical device’, and explains that:
“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.”
Also available is an updated form to be completed for a ‘post-consultation procedure on an ancillary medicinal substance in a medical device’, when any changes are planned for the initially cleared product.