Consultation process for medical devices incorporating a medicinal substance
Information for applicants on the process and requirements for Drug-Device Consultations submitted to the HPRA by notified bodies.
Medical devices may contain a substance that is an integral part of the medical device, a substance which, if used separately is a medicinal product (ancillary substance). Manufacturers of medical devices containing ancillary medicinal substances are required to provide the notified body with appropriate safety, quality and usefulness data with regard to the medicinal substance contained within the device. Notified bodies in turn are required to consult with one of the national competent authorities for medicinal products within the EU or the European Medicines Agency for verification of the quality and safety of the substance including the clinical benefit/risk profile of the incorporation of the substance into the device.
The opinion given by the competent authority will be taken into account in the overall assessment made by the notified body; however the notified body takes the final responsibility for certification of the medical device.
The HPRA is the competent authority for medicinal products in Ireland and may be consulted by a notified body for verification of the quality safety and usefulness of a medicinal substance in a medical device.
The HPRA Guide to Drug-Device Consultations provides further information on the application process and information required. The application by a notified body for a consultation should be made using the HPRA application form: Application for a Drug Device Consultation. Information on fees is available in the Guide to Fees for Human Products.
For any queries or for information on supplementary consultations please contact us via the email address info@hpra.ie