The European Parliament has adopted new regulations for in vitro diagnostic medical devices and medical devices to enhance public health and patient safety.

Proposed by the European Commission in 2012, the new regulations are meant to ensure the safety and performance of all medical devices.

The three existing directives on medical devices will now be replaced by the two new regulations, which are set to provide improved market surveillance, traceability, transparency and legal certainty for producers, manufacturers and importers.

High-risk devices such as implants will be under tighter control and will require consultation of a pool of experts at European Union (EU) level.

"High-risk devices such as implants will be under tighter control and will require consultation of a pool of experts at European Union (EU) level."

Controls on clinical trials and bodies with authority to approve the marketing of devices will also be tightened and certain previously unregulated aesthetic products, such as coloured contact lenses, will also be addressed.

In addition, a new system for risk classification in accordance with international guidelines will be applied to in vitro diagnostic medical devices.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The new regulations include patient benefits, such as an EU database on medical devices (EUDAMED) with a live picture of all the EU market products, a new device identification system, an implant card with details on implanted medical devices and financial coverage.

They will also cover security and regulatory certainty of drug-device combination products, nanoscience, tissue engineering, personalised medicine and genetic tests.

The new rules will be applicable after three years of official publication for medical devices and after five years for in vitro diagnostic medical devices.