The new EU Medical Device Regulation (the “MD Regulation”) and the EU In vitro Diagnostics Regulation (the “IVD Regulation”) (together, the “Regulations”) were adopted by the European Parliament on 6 April and are set to be published in the Official Journal in May. The MD Regulation will apply from 2020 and the IVD Regulation will apply from 2022.

There are over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EEA market and the size of the market is reportedly EUR 100 billion. Medical devices range from contact lenses and sticking plasters to pace makers and hip replacements. In vitro diagnostic include HIV blood tests, pregnancy tests and blood sugar monitoring systems for diabetics.

The European Commission proposed the new rules relating to medical devices in late 2012 following scandals involving silicone breast implants and metal-on-metal hip joint replacements, however the European Commission, European Parliament and European Council did not reach agreement on the rules until May 2016.

The Regulations comprise a new regulatory framework for medical devices in the EU. The European Commission’s stated goals in overhauling the regime include improving the quality, safety and reliability of medical devices, strengthening transparency of information for consumers and enhancing vigilance and market surveillance. The main changes brought about by the new Regulations include:

  • greater scrutiny through unannounced audits, physical tests and laboratory tests on medical devices by regulatory bodies;
  • greater responsibility (and therefore potential liability) for manufacturers, importers and distributors within the supply chain;
  • additional review and scrutiny for certain products and manufacturers of medical devices; and
  • increased post-market surveillance and vigilance requirements, for example a requirement for periodic safety update reports. 

The Regulations will come into force after the currently expected date for the UK’s exit from the EU. However, the rules will apply to all products placed on the EEA market and therefore UK businesses will need to comply with them if they are trading in the EEA. In addition, it is currently anticipated that all EU-derived law will become part of UK law at the date the UK leaves the EU, and therefore the new Regulations will apply in the UK unless they are expressly repealed or amended by Parliament.