Regulatory information
This webpage provides links to specific topics for medical devices and in vitro diagnostic medical devices (IVDs).
It also gives a short overview of what medical devices and IVDs are and how we regulate them in Ireland and the EU.
What is a medical device?
A medical device is used for a medical purpose and acts in a physical manner and not through pharmacological, immunological or metabolic means. Medical devices help patients and healthcare providers in the diagnosis, prevention, prediction, monitoring, prognosis or treatment of a disease, injury or disability.
Examples of medical devices include hospital beds, surgical instruments, syringes, wheelchairs, walking frames, contact lenses, condoms, heart valves, pacemakers, hip implants, MRI machines and more.
What is an IVD?
An IVD is a medical device that is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus or software system. IVDs may provide information on a physiological or pathological state or monitor therapeutic measures in vitro (outside of the body).
IVDs include pregnancy test kits, urinalysis test strips and specimen tubes such as blood collection tubes.
How are medical devices and IVDs regulated?
The EU Commission introduced two new Regulations for medical devices and IVDs in 2017.
The Medical Devices Regulation (MDR) outlines requirements for medical devices. The MDR applies directly to all EU member states. National S.I.s (such as S.I. 547/2017, S.I. 261/2021 and S.I. 691/2021) outline specific national requirements.
The In Vitro Diagnostic Medical Devices Regulation (IVDR) outlines requirements for IVDs. Like the MDR, the IVDR applies directly in all EU member states. National S.I.s (such as S.I. 365/2022, S.I.256/2022 and S.I 547/2017) outline specific national requirements.
Further information
Please follow the menu below for more information about the MDR or IVDR.
This page contains information on topics relevant to both the Medical Device Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR).
This page contains specific information on topics relevant to the Medical Device Regulation (MDR).
This page contains specific information on topics relevant to the In Vitro Diagnostic Regulation (IVDR).