List of views provided under the CECP
This page lists all published expert decisions and opinions in the context of the Clinical Evaluation Consultation Procedure (CECP) according to Article 54 of Regulation (EU) 2017/745).
The consultation procedure might be relevant to you, if you are a manufacturer of one of the following devices (exceptions, see Article 54 (2) MDR):
(a) class III implantable devices, or
(b) class IIb active devices intended to administer and/or remove a medicinal product, as referred to in Section 6.4 of Annex VIII (Rule 12).
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Single chamber, extravascular implantable cardioverterdefibrillator (ICD)
Circulatory system
Fully resorbable mesh
General and plastic surgery and dentistry
Resorbable mesh for soft tissue deficiencies
General and plastic surgery – Dentistry
Anatomic shoulder prosthesis
Orhopaedics – Traumatology – Rehabilitation – Rheumatology
Bone Graft Material for Dentistry
General and plastic surgery – Dentistry
Native Tricuspid Valve Replacement
Circulatory system
Transcatheter Heart Valves and Delivery System
Circulatory system
Percutanoeus Pulmonary Valve and Delivery System
Circulatory system
Combination System for Total Hip Replacement
Orhopaedics – Traumatology – Rehabilitation – Rheumatology