The European Medicines Agency (EMA) has published an updated list of opinions issued by Expert Panels under the Clinical Evaluation Consultation Procedure (CECP) for medical devices undergoing conformity assessment.
The list is dated 22 September 2026 and is intended to enhance transparency around the work of the Expert Panels. EMA states that the individual CECP opinions will be published once the conformity assessment for the relevant medical devices has been finalised by the Notified Body (NB).
What Is Included in the List?
The EMA table provides information on each CECP dossier, including:
date of opinion;
CECP dossier number;
medical device type according to EMDN level 3;
device risk class or type;
medical area;
reason for the opinion, identified by the applicable CECP criterion.
The current list includes opinions issued between November 2024 and April 2026.
High-Risk Medical Devices
Most of the listed devices are Class III implantable devices, reflecting the role of the CECP in the assessment of certain high-risk medical devices.
Medical areas represented in the list include:
circulatory system;
orthopaedics, traumatology, rehabilitation and rheumatology;
general and plastic surgery;
dentistry;
ophthalmology;
obstetrics and gynaecology;
neurology.
Class IIb Active Device
The list also includes a Class IIb active device intended to administer or remove medicinal products, classified under EMDN code Z1203.
The opinion, dated 10 January 2025, concerns the medical areas of respiratory care, anaesthesiology and intensive care.
CECP Criteria
The table also identifies the reason for each Expert Panel opinion.
Most of the entries are associated with Criterion 1, while one listed Class III implantable orthopaedic device is associated with Criterion 2.
The publication itself does not provide additional explanations of the criteria; instead, it records which criterion applied to each dossier.
Recent 2026 Opinions
The most recent opinions shown in the updated list are:
17 February 2026 — a Class III implantable device in the field of neurology;
21 April 2026 — a Class III implantable device in orthopaedics, traumatology, rehabilitation and rheumatology.
Both are listed under Criterion 1.
Publication of Individual Opinions
EMA clarifies that the actual CECP opinions will only be published once the conformity assessment for the relevant medical device has been completed by the Notified Body.
This means the transparency list may show that an Expert Panel opinion has been issued before the full opinion document becomes publicly available.
Impact on Medical Device Manufacturers and Notified Bodies
For manufacturers of high-risk medical devices, Notified Bodies and regulatory teams, the updated list provides useful visibility into the types of devices and medical areas currently reaching the Expert Panel consultation stage.
Stakeholders should pay particular attention to:
Class III implantable devices;
Class IIb devices involving medicinal product administration or removal;
CECP dossier tracking;
Expert Panel involvement in conformity assessment;
applicable CECP criteria;
EMDN classification;
timing of opinion publication;
coordination between Expert Panels and Notified Bodies.
For manufacturers preparing conformity assessments for devices potentially subject to CECP, the list provides an additional transparency reference for understanding the types of devices and clinical areas that have recently undergone Expert Panel review.
Abbreviations
The EMA document defines:
CECP — Clinical Evaluation Consultation Procedure;
EMDN — European Medical Device Nomenclature;
MD — Medical Device;
NB — Notified Body.
