U-Prevent achieves MDR certification as a Class IIa Medical Device

U-Prevent has been officially certified under the Medical Device Regulation (MDR) as a Class IIa medical device. This marks the successful transition from the previous Medical Device Directive (MDD) to the MDR.

This milestone represents an important step forward in ensuring the continued quality, safety, and future readiness of U-Prevent, in line with current European regulatory standards.

Building on a strong foundation

U-Prevent was previously certified under the MDD and has been used in clinical practice for several years. The transition to MDR builds on this established foundation and aligns the solution with the latest regulatory requirements for medical devices.

The certification is the result of a thorough preparation for MDR and ISO 13485, combined with the efforts of a broad network of partners and the dedication of the teams involved.

From academic initiative to MDR-compliant solution

U-Prevent originated at UMC Utrecht and has been further developed under ORTEC into a fully rebuilt, MDR-compliant solution. This strong foundation enabled an efficient and well-controlled certification process.

Looking ahead

With MDR certification in place, U-Prevent is well positioned for further development. Together with healthcare professionals and users, future efforts will focus on enhancements and extensions that support:

• Prevention of cardiovascular disease
• Personalized care
• Shared decision-making with patients

More information

Learn more about U-Prevent: u-prevent.com