Documents and Guidance 

EU Guidance 

The HPRA is an active contributor to the development of many guidance documents through various EU working groups and taskforces. These documents are developed collaboratively through active participation from the EU Commission, national competent authorities and stakeholder groupings involving industry, healthcare professionals and patient advocacy groups. These collaborative efforts help ensure a harmonised approach across Europe and provide clarity to EU stakeholders. MDR/IVDR documents and guidance endorsed by the Medical Device Co-ordination Group (MDCG) can be found here. Please also see the HPRA MDR/IVDR Legislation page.

The European Commission has developed a dedicated webpage to the EU Device Regulations and has published a number of factsheets, which provide useful guidance to key stakeholders. Some of these factsheets are linked below:

Guidance under the current directive on in-vitro diagnostic devices can be found here.

UDI Helpdesk

The Unique Device Identification (UDI) system was introduced under the MDR/IVDR to facilitate easier identification and traceability of medical devices. The European Commission has launched a UDI helpdesk to support economic operators in meeting their UDI obligations. These include UDI assignment, labelling, and registration of devices. The helpdesk will also provide support in usage of the European Medical Devices Nomenclature (EMDN).

CAMD Guidance – Transitional Provisions 

The Competent Authorities for Medical Devices (CAMD) network published FAQ documents covering the transitional provisions of the MDR and IVDR. These documents were developed by the CAMD Transition Subgroup (TSG), which was tasked with agreeing and providing greater clarity on the transition-related provisions in the new Regulations.

HPRA Guidance

Information on implementation of the EU Device Regulations is published on our website, which includes an Introductory Information Pack. This is a useful resource for newly established entities in the medtech sector. The HPRA has also a number of guidance documents specific to Irish stakeholders, which are updated periodically.

Below are some guidance documents that are a useful resource on the fundamental principles of the medical device regulatory framework:

Brexit Guidance

The HPRA has a dedicated Brexit webpage, which contains a section specific to Medical Devices. The purpose of these pages is to provide information for stakeholders on Brexit and help ensure manufacturers, authorised representatives, distributors and suppliers are prepared for the end of the Brexit transition period.