The new EU regulation on Medical Devices

On Friday, 5th of May, the new regulations on medical devices were published in the Official Journal of the European Union:

  • a Regulation on medical devices (MDR)
  • a Regulation on in-vitro diagnostic medical devices (IVDR)

According to the European Commission, the new Regulations, which were approved by the European Parliament on 5th of April 2017, provide greater patient safety and modern public health. The new rules emphasize improved traceability, quality and reliability of medical devices.

Among other things, the new Regulations on medical devices bring: 

  • stricter control for high-risk devices,
  • stricter requirements for clinical evaluation,
  • the strengthening of post-market surveillance requirements for manufacturers (more information for patients),
  • unannounced audits of manufacturers / production after placing medical devices on the market,
  • greater traceability of medical devices, including end users,
  • greater transparency and legal certainty for manufacturers and importers;
  • greater market surveillance,
  • strengthen the international competitiveness and innovation,
  • improved security and focus on the performance of products.

The new rules will enter into force until after the transitional period, i.e. 3 years after the publication of the Regulations on medical devices (spring 2020).