General introduction/background info on agreement at EU level
In June 2016, two new proposed Regulations on medical devices (MDR) and in-vitro diagnostics (IVDR) were agreed at political level between the three relevant European institutions – the European Council, the European Parliament and the European Commission. Since then these texts have been undergoing final review, translations in the different European languages and formal approval.
The HPRA anticipate that these Regulations will be formally published in the Official Journal of the European Union by the end of April 2017. This means that both Regulations will enter into force during quarter 2 of 2017. The Regulations will have a staggered transitional period with some aspects becoming legally binding after 6 months, full application of the MDR after 3 years and full application of the IVDR after 5 years.
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.