Medical Device Regulations (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulations (EU) 2017/746

Overview of medical and in vitro diagnostic medical devices

Medical devices and in vitro diagnostic medical devices, have an important function in protecting patients and public health by diagnosing, preventing, monitoring, predicting, treating and / or alleviating various illnesses.

A medical device is a health product or piece of equipment that is used for a medical purpose, which can be used to diagnose, monitor, or treat illness and also, to assist people with physical impairments to improve their quality of life. The range of medical devices available is very broad and is constantly evolving as new devices emerge. Examples of medical devices range from less complex products, such as plasters and bandages to increasingly more complex products from wheelchairs to contact lenses, blood pressure meters and pregnancy test kits, incubators, ventilators, hip implants, coronary pacemakers, catheters and stents.

An in vitro diagnostic medical device is a medical device used to test biological samples (for example blood or urine) in order to assess a person's health status. Examples of these tests include pregnancy test kits, urine test strips and specimen receptacles (such as blood collection tubes).

Regulation of medical and in vitro diagnostic medical devices

In the European Union (EU), medical and in vitro diagnostic medical devices are regulated by a European Union framework which aims to ensure that all devices available for use on the EU market are safe and perform as intended.

Until April 2017, this framework consisted of three EU Directives (a type of legislative act whereby each Member State must devise their own laws to meet the goals set out by the Directives) on medical and in vitro diagnostic devices. In April 2017, two new pieces of EU law on medical and in vitro diagnostic medical devices were introduced to replace the previous laws (the Directives) in place. These two new pieces of legislation are in the form of two Regulations - this means that the new legislation applies directly to all EU Member States. The Department of Health is required to introduce additional national legislation to give effect to specific aspects of these new Regulations. This national legislation is available via the Iris Oifigiúil website (the official Irish State gazette.)

These two new Regulations, namely, Regulation (EU) 2017/745 relating to medical devices (MDR) and Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices (IVDR), entered into force following publication in the Official Journal of the European Union in April 2017. To help with a smooth transition from the previous to the new legislation, transitional periods applied, as set out in the Regulations.

These new Regulations aim to strengthen the EU wide regulatory framework for medical and in vitro diagnostic devices, to account for the increasing complexity of medical device technologies and to address weaknesses within the current system. The new Regulations ultimately aim to provide a secure, consistent regulatory framework for all medical devices and to enhance public health across the EU by ensuring that medical devices are safe, perform as intended and afford benefits to patients and healthcare systems.

The MDR was due to become fully applicable on 26 May 2020 after a three-year transition period, however, due to the global outbreak of Covid-19 full implementation of the MDR was deferred and it became fully applicable on 26 May 2021. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period.

Both the MDR and IVDR place specific obligations on various stakeholders throughout the supply chain, including manufacturers, authorised representatives, distributors, importers and healthcare institutions. Requirements for each stakeholder involved in the medical device sector are clearly defined and set out in the Regulations. The Department of Health encourages all stakeholders affected by the MDR and IVDR to identify how they are impacted by the new Regulations and ensure timely compliance with all requirements.

In Ireland, the Health Products Regulatory Authority (HPRA) is the designated national competent authority and market surveillance authority for medical devices and in vitro diagnostic medical devices. This means they are responsible for regulating Medical Devices and in vitro Medical Devices in Ireland. The HPRA has a specific regulatory role involving the designation of notified bodies, authorisation of clinical investigations and monitoring the safety and compliance of medical devices in Ireland, through market surveillance activities after they are placed on the market. The HPRA is the national authority responsible for enforcing the MDR and IVDR. This information is technical and for further clarification on certain aspects please contact the HPRA website directly HPRA website.

The Department of Health is working closely with the HPRA and other key stakeholders to ensure Ireland's timely and effective application of the new Regulations.