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 at EU Member State level, but EMA, through panels of experts in medical devices, is involved in the regulatory process for some types of devices.

For certain high-risk devices, EU legislation requires notified bodies to consult the expert panels before issuing a CE certificate.

These high-risk medical devices 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 should be provided on the clinical evaluation assessment report.

48 applications for CECP were screened in 2023, over 60 % more than in 2022. The screening experts decided that an opinion was needed for one of these CECP applications.

When it comes to PECPs, in 2023 expert panels issued opinions for two 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 2023, three such procedures were finalised.

In line with EU legislation, the expert panels provide advice to the Medical Device Coordination Group (MDCG), which finalised three advice procedures in 2023.

Figures on opinions by expert panels on high-risk medical devices