Medical devices: expert panel advice at the request of the Medical Device Coordination Group and the European Commission

The European Medicines Agency (EMA) publishes the advice of medical device expert panels on medical devices.

Medical device expert panels deliver the advice on request from the European Commission, the Medical Device Coordination Group (MDCG), national competent authorities in EU Member States, manufacturers, and notified bodies if needed.

The legal basis is the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746).

The advice covers the following types of device:

• 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

More information:

• Consultation procedures for high-risk medical devices
• Medical device expert panels

Orthopaedics, traumatology, rehabilitation, rheumatology

Currently, there is no advice in this field.

Circulatory system

Advice on the use of paclitaxel-coated devices in peripheral artery disease and potential association with higher mortality, on request from the Medical Device Coordination Group - 5 August 2024

Neurology

Currently, there is no advice in this field.

Respiratory system, anaesthesiology, intensive care

Currently, there is no advice in this field.

Endocrinology and diabetes

Currently, there is no advice in this field.

General and plastic surgery and dentistry

Currently, there is no advice in this field.

Obstetrics and gynaecology, including reproductive medicine

Currently, there is no advice in this field.

Gastroenterology and hepatology

Currently, there is no advice in this field.

Nephrology and urology

Currently, there is no advice in this field.

Ophthalmology

Currently, there is no advice in this field.

In vitro diagnostic medical devices

Advice related to classification of SARS-CoV-2 devices on request from the Medical Device Coordination Group

Advice on mpox virus on request from the Medical Device Coordination Group

Advice on SARS-CoV-2 neutralising antibodies on request from the Medical Device Coordination Group

Advice on indirect antiglobulin tests on request from the Medical Device Coordination Group

Advice on the influenza virus on request from the Medical Device Coordination Group