European Union’s New Medical Device Regulation

On May 26th, 2016, after much awaited time, the European Union has reached an agreement on the regulations for medical devices and in vitro diagnostics. You are probably asking yourself: what exactly are these changes? what are the aims of these new rules? what do these changes mean for my company?

The European Union’s new Medical Device Regulation (MDR) will bring substantial changes to the way that medical devices make their way to the market and how they are regulated once on the market.

Existing rules date back to the 1990s and are out of date with current scientific advances in the medical device sector. Currently, it is not always possible to attain information on who produced devices sold in the European Union. Moreover, there is a lack of clinical information showing that the devices are safe and effective for patients.

The aim of these new rules is to make sure that medical devices and in vitro diagnostic medical devices are safe and effective as well as providing patients with health care solutions in a timely manner. Improving the safety of medical devices will be done by:

  • Strengthening the regulations on placing devices on the market.
  • Tightening surveillance and compliance regulations once they are available.

Some high risk devices, such as implants, may undergo an additional scrutiny by experts before being brought to the market. Additionally, there is a need for improved transparency and increased traceability for patients. The creation of a central database will contain all pertinent information.

The First Reading Drafts will be published mid-June and the Regulations will be adopted in the fall 2016. There will be a three-year transition period for medical devices and a five-year transition for IVDs.

What does the transition period mean for your devices? Manufacturers whose devices are CE Marked for sale in the European Union will have until the fall of 2019 to prepare for the new medical device regulations and until the fall of 2021 for IVD regulations.

The agreement is still subject to the approval by the Council’s Permanent Representatives Committee and of the Parliament’s ENVI committee.

For more information, check out:

European Council Press Release

Modernizing EU Rules for Medical Devices