Drug-Device Consultations
This page provides information for applicants on the process and requirements for Drug-Device Consultations submitted to the HPRA by notified bodies.
What is a Drug-Device?
Medical devices are generally used for a medical purpose through a physical manner and not pharmacological, immunological, or metabolic means. However, some medical devices may contain a substance that is an integral part of the medical device and when the substance is used alone it is a medicinal product.
These ‘drug-devices’ are regulated by both the Medical Devices Regulation (MDR) and the Medicinal Products for human use Regulation (Directive 2001/83/EC). The general safety and performance requirements for the device part are given in the MDR and are assessed in the context of the marketing authorisation for the medicinal product.
What is the Consultation Process?
The notified body should be provided with safety, quality, and usefulness data for the drug-device by the manufacturer of the drug-device.
The notified body consults with a national Competent Authority for medicinal products within the EU or the European Medicines Agency (EMA).
The national Competent Authority or the EMA verify 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 or EMA will be considered 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 in this process.
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 info@hpra.ie.
Further information
The 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 info@hpra.ie.
Guide to drug-device consultations PDF : 157 KB | 02/06/2008 Application for a drug-device consultation DOCX : 91 KB | 02/06/2008