Medical devices

In the EU, medical devices must undergo assessments to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. They are regulated by notified bodies at EU Member State level, but EU legislation requires that expert panels coordinated by EMA are consulted before issuing a CE certificate for certain high-risk medical devices. These include:

• Class III implantable devices and class IIb active devices that are intended to administer or remove medicinal products from the body; and
• Class D in vitro diagnostic medical devices.

The expert panels can provide:

• opinions on the notified body’s assessment of the manufacturer’s clinical file of class III and class IIb medical devices, known as the clinical evaluation consultation procedure (CECP); and
• views on the manufacturer’s performance evaluation report of class D in vitro diagnostic medical devices, known as the performance evaluation consultation procedure (PECP).

CECP dossiers are first reviewed by the screening experts, who decide whether or not an opinion needs to be provided on the clinical evaluation assessment report. Their decision is based on the novelty of the device, any significant health concerns, including device components and the health impact of the failure of the device, and increased rates of reported serious incidents.

A total of 115 applications for CECP were screened in 2025, nearly 60 % more than in 2024. The screening experts decided that an opinion was needed for 11 of these CECP applications.

In addition, the expert panels provide scientific advice for manufacturers of high-risk medical devices. In 2025, nine such procedures were finalised.

EMA continued the pilot on orphan medical devices in 2025. Five requests for orphan designation and two requests for clinical advice were finalised.