Medical devices and IVDs – regulatory documents and guidance
This webpage provides you with links to national and EU guidance documents databases relating to the application of the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).
HPRA guidance documents
Our guidance documents set out national positions on the application of the MDR and IVDR for economic operators based in Ireland. Our documents represent our current thinking on specific topics. We update our documents as needed. Our documents do not purport to be an interpretation of law and are for guidance purposes only.
We have published several webinar recordings and presentations for economic operators based in Ireland. Our webinars provide useful information on the practical application of the MDR and IVDR from both a national and EU perspective. See our webinars on both MDR and IVDR held in 2020 and our webinars on IVDR held in 2022.
We publish newsletters which address topical subjects and questions relating to devices. These newsletters provide practical information and are relevant to all stakeholders including manufacturers, healthcare institutions and importers.
You can sign up to be notified of new publications through the My HPRA service.
Our newsletters are accurate at the time of publication. You should consult our webpages and guides for the most up-to-date information.
Medical Device Coordination Group (MDCG)
MDCG guidance documents set out EU positions concerning the application of the MDR and IVDR. MDCG guidance documents cover key issues such as notified body oversight, EUDAMED and device classification amongst others.
Under the MDR and IVDR, expert panels have been set up to, amongst other things, contribute to the development and maintenance of guidance documents, common specifications and international standards. Find out more about the role of expert panels and to review expert panel publications.
European Commission factsheets
The European Commission has developed several factsheets. These fact sheets provide an overview of some of the practical applications of the MDR and IVDR such as device nomenclature, implantable devices and economic operator obligations. Some fact sheets may also be relevant to health institutions.
Competent Authorities for Medical Devices
The Competent Authorities for Medical Devices (CAMD) is an umbrella group, under which EU competent authorities work to enhance collaboration within the field of medical devices. Here, you can find useful links and presentations from across the CAMD network, as well as publicly available outputs from the joint actions and working groups.
The MDR and IVDR introduced the Unique Device Identification (UDI) system to allow for the easier identification and traceability of medical devices. The UDI helpdesk aims to support economic operators in meeting their UDI obligations.