EMA Updates List of CECP Opinions Issued by Medical Device Expert Panels
The European Medicines Agency, EMA, has updated its list of Clinical Evaluation Consultation Procedure, or CECP, opinions issued by the Expert Panels for medical devices undergoing conformity assessment.
The list is intended to enhance transparency on the work of the Expert Panels. According to EMA, the CECP opinions listed will be published once the conformity assessment for the relevant medical devices is finalised by the Notified Body, and the list will be updated accordingly.
Scope of the List
The table includes CECP opinions issued for medical devices undergoing conformity assessment.
For each entry, EMA provides the date of opinion, CECP dossier number, medical device type according to EMDN level 3, risk class or type, medical area and the reason for opinion under criteria 1, 2 or 3.
Devices and Medical Areas Covered
The listed opinions mainly concern class III implantable devices, with entries covering medical areas such as the circulatory system, general and plastic surgery, dentistry, ophthalmology, orthopaedics, traumatology, rehabilitation, rheumatology, obstetrics and gynaecology, and neurology.
The table also includes one class IIb active device intended to administer or remove medicinal products, associated with respiratory, anaesthesiology and intensive care.
Reasons for Opinion
Most entries in the list are marked as Criterion 1, while one entry is marked as Criterion 2.
The Criterion 2 entry relates to a class III implantable device in orthopaedics, traumatology, rehabilitation and rheumatology.
Abbreviations Used
EMA defines the abbreviations used in the list as follows:
CECP — Clinical Evaluation Consultation Procedure;
EMDN — European Medical Device Nomenclature;
MD — Medical Device;
NB — Notified Body.
Impact on Medical Device Manufacturers
For manufacturers of high-risk medical devices, especially class III implantable devices and certain class IIb active devices, the updated EMA list is relevant because it provides visibility into the types of devices and medical areas that have undergone CECP review.
Manufacturers should pay particular attention to:
whether their device type may fall within CECP scope;
the applicable EMDN level 3 classification;
the relevant medical area;
interaction between Expert Panels and Notified Bodies;
timing of CECP opinions during conformity assessment;
publication of CECP opinions after finalisation of conformity assessment;
transparency expectations under the MDR.
For manufacturers preparing conformity assessment for high-risk devices, the list reinforces the importance of planning for potential Expert Panel involvement and ensuring that clinical evaluation documentation is robust, well-structured and aligned with MDR expectations.
