Software more often qualified as a medical device

This information is provided by

Netherlands Enterprise Agency, RVO

Effective date: 26 May 2021

What changes?

Do you manufacture medical software? As of 26 May 2021 the new European regulation on medical devices (MDR) will come into force. This changes the definition of medical devices. This means that medical software that right now is not subject to the medical devices Act (Wet op de medische hulpmiddelen, in Dutch) may be qualified as a medical device.

If your software is qualified as a medical device under the MDR? Then it must comply with the requirements. Under this new legislation your software may also be classified as a higher risk and stricter safety requirements apply.

For whom?

  • manufacturers of medical software

When?

The European directive on medical devices (MDR) was set to come into force on 26 May 2020. Due to the COVID-19 crisis, this has been postponed to 26 May 2021.

This information is provided by

Netherlands Enterprise Agency, RVO