New EU-legislation for medical devices

The new EU Regulation on Medical Devices and the Norwegian Act on Medical Devices entered into force on May 26th 2021.

The three EU Directives on Medical Devices are being replaced by the two EU Regulations 2017/745 on Medical Devices (MDR) and 2017/746 on In Vitro Diagnostics (IVDR). IVDR will, however, not entry into force until May 26th 2022.

Norway has the same rights and obligations as other EU Member States with regard to requirements for medical devices and the EEA Agreement and the Norwegian Act on Medical Devices implement the above-mentioned Regulations.

Medical Devices concerned by the regulations may be any medical device, being everything from contact lenses to advanced pace-makers. The different regulations will ensure safe usage throughout the whole life of the device to avoid any user damage or danger for patients and users.

The legislative changes are the most comprehensive since the legislation for medical devices arose in the 90's and the changes shall reflect the technological and scientific development made the past 20 to 30 years. The purpose of the changes is to ensure patient safety by having common legislation for safe and efficient medical devices throughout Europe.

For more information on medical devices in Norway, please see the Norwegian Medicines Agency's web site here or contact our legal team.