High-risk medical devices

Consultation procedures and advice for high-risk medical devices, including information on the panels and how to participate in them.

For certain high-risk devices, notified bodies need to consult expert panels before issuing a CE (Conformité Européenne) certificate.

This is in line with the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746). 

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
• Class D in vitro diagnostic medical devices (where no common specifications are available and when it concerns the first certification for that type of device)

EMA provides administrative, technical and scientific support to the expert panels.

This is in accordance with the Regulation on EMA's Reinforced Role (Regulation (EU) 2022/123).

For more information, see:

• Medical devices
• Medical device expert panels

In this section: Guidance

Consultation procedures

Guidance on the consultation procedures conducted within the EU conformity assessment process for specific high-risk medical devices

Scientific advice for high-risk medical devices

Guidance for manufacturers on requesting clinical advice from EMA through the expert panels for high-risk medical devices

In this section: Opinions, views and advice

Class III implantable devices and Class IIb medical devices

Opinions of medical device expert panels on Class III implantable devices and Class IIb devices intended to administer or remove medicinal products

Class D in vitro diagnostic devices

Views of the in-vitro diagnostics expert panel on Class D in vitro diagnostic devices and information on ongoing consultations

Expert panel advice

Advice of the expert panels on request from the European Commission, the Medical Device Coordination Group (MDCG), national competent authorities in EU Member States, manufacturers, and notified bodies

Join a medical device expert panel

Experts with clinical or scientific expertise in relevant medical fields can apply to join a medical device expert panel. Panel members are remunerated and serve renewable terms.

Learn about joining a panel

Page update history

An update log is available to show the date and summary of changes to this webpage. It does not include updates to linked documents or minor edits like typos or broken link fixes.

The tracking of updates begins in March 2026.

See update history

2 March 2026

Page first published; Content has been moved from another webpage as part of a broader content reorganisation