Class III implantable devices and Class IIb medical devices intended to administer or remove medicinal products: expert panel opinions

The European Medicines Agency (EMA) publishes the opinions of medical device expert panels on Class III implantable devices and Class IIb devices intended to administer or remove medicinal products.

Medical device expert panels deliver these opinions as part of the clinical evaluation consultation procedure (CECP). The legal basis is Article 54 of Regulation (EU) 2017/745.

Opinions are displayed under the topics handled by different expert panels.

Disclaimer: These CECP opinions are issued by the expert panels for medical devices during the process of conformity assessment. The notified body is required to take into account the views expressed in the expert panel’s scientific opinion. However, the opinion does not represent or indicate the certification status of the medical device once the conformity assessment activities are completed by the notified body.

More information:

• Consultation procedures for high-risk medical devices
• Expert panel views on class D in vitro diagnostic devices
• Medical device expert panels

Orthopaedics, traumatology, rehabilitation, rheumatology

Bioabsorbable orthopaedic screws - Notified body 0344 - 14/05/2024 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Structures filling, replacement and reconstruction devices - Notified body 1434 - 07/04/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Shoulder prostheses - Notified body 0459 - 25/08/2022 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Hip prostheses - Notified body 2797 - 22/10/2021 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Circulatory system

Implantable cardiac devices (various) - Notified body 2797 - 15/07/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Cardiac valves - Notified Body 0344 - 07/12/2021 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Drug-Eluting stent (DES) - Notified Body 2265 - 10/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Implantable cardiac devices (various) - Notified body 0123 - 11/11/2023 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Vascular and cardiac endoprostheses - Notified body 0344 - 05/07/2022 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Cardiac valves - Notified body 0344 - 27/06/2022 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Cardiac valves - Notified body 0344 - 23/05/2022 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Neurology

Cerebral implantable neurostimulators - Notified body 0344 - 01/08/2022 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Respiratory system, anaesthesiology, intensive care

Mechanical ventilator - Notified body 2696 - 10/01/2025 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Endocrinology and diabetes

Currently, there are no expert panel opinions in this field.

General and plastic surgery and dentistry

Surgical meshes - Notified body 2797 - 10/06/2024 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Surgical meshes - Notified body 2797 - 06/10/2022 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Structures filling, replacement and reconstruction devices - Notified body 0483 - 15/06/2021 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Obstetrics and gynaecology, including reproductive medicine

Currently, there are no expert panel opinions in this field.

Gastroenterology and hepatology

Currently, there are no expert panel opinions in this field.

Nephrology and urology

Male genital system prostheses - Notified Body 0477 - 17/04/2023 - Expert decision and opinion in the context of the clinical evaluation consultation procedure (CECP)

Ophthalmology

Currently, there are no expert panel opinions in this field.

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The tracking of updates begins in April 2026.

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29/04/2026

Disclaimer added to page introduction