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.

Seventy-three applications for CECP were screened in 2024, over 50 % more than in 2023. The screening experts decided that an opinion was needed for six of these CECP applications.

When it comes to PECPs, in 2024 expert panels issued opinions for four applications.

In addition, EMA is running a pilot that enables the expert panels to provide scientific advice for manufacturers of high-risk medical devices. In 2024, 17 such procedures were finalised.

In line with EU legislation, the expert panels provided two advice reports upon request of the Medical Device Coordination Group (MDCG).

EMA also launched a pilot on orphan medical devices in August 2024, which is scheduled to run until the end of 2025. As of December 2024, six applications have been received.