New EU MDR/IVDR Legislation

General introduction/background info on agreement at EU level

Regulation 2017/745 on Medical Devices (MDR) and Regulation 2017/746 on In-Vitro Diagnostic Devices (IVDR) were agreed at a political level between the three relevant European institutions  (the European Council, the European Parliament and the European Commission) and entered into force in May 2017 following publication in the Official Journal of the European Union. The Regulations have a staggered transitional period with some aspects becoming legally binding after 6 months of entry into force. 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 application of the MDR has been postponed and will become fully applicable on 26 May 2021. The IVDR will be fully applicable on 26 May 2022, after a five-year transition period.

The MDR and IVDR represent a significant development and strengthening of the existing regulatory system for medical devices in Europe and will replace the original Directives which have been in place for over 25 years.

The legislation now being in the form of a Regulation, rather than a Directive, means that the EU law is directly applicable at national level without requiring transposition through specific national legislation. This should allow for greater legal certainty and prevent variation in the approach taken or in the rules relating to medical devices that are applied across EU Member States.

This webpage will be updated regularly to provide additional information on the new Regulations and their implementation.

If you have any questions about the regulation of medical devices, or queries about any particular products, please e-mail devices@hpra.ie

Stakeholders wishing to receive legislative updates including regular communication on the new Regulations can sign up by emailing devices@hpra.ie