According to Article 54 of the Medical Devices Regulation (MDR), Notified Bodies have to follow a Clinical Evaluation Consultation Procedure (CECP) when performing a conformity assessment of certain high-risk devices. In particular, this procedure applies to class III implantable devices and class IIb active devices intended to administer or remove a medicinal product (ARMP devices).
In January 2023, the Commission published the “Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54(4) of Regulation (EU) 2017/745 on medical devices”. The document covers the period between April 2021 and June 2022.
Notification to the authorities and derogation
When a medical device falls under the scope of Article 54 (1), namely ARMP devices, the Notified Body has to send a notification to the competent authority, the authority responsible for notified bodies, and the Commission through EUDAMED. This notification informs the authority of whether or not the consultation procedure applies.
If the procedure does not apply, the Notified Body has to indicate the reason. Specifically, the condition for a derogation to the CECP procedure are:
- Renewal of certificate issued under MDR.
- The same manufacturer designed a device with the same intended purpose as their previous one, demonstrating to the NB that the modifications do not affect the benefit-risk ratio.
- The Common Specifications address principles of the clinical evaluation of the device type or category and the Notified Body confirms the compliance of this device with the relevant Common Specifications.
CECP applications and exemptions
Between April 2021 and June 2022, the Authorities recorded 215 notifications. Out of 215 devices, Notified Bodies applied the CECP procedure to 24 devices. Overall, more than half of the CECP devices fell within the following categories: implantable cardiac devices such as pacemakers, defibrillators and insertable cardiac monitors, vascular and cardiac prostheses, and orthopaedic prostheses. When a device requires a Clinical Evaluation Consultation Procedure, the expert panel for medical devices can issue a scientific opinion. Among the 24 CECP procedures, the expert panel issued an opinion for six of them (one under development). Notified Bodies adopted all five delivered opinions.
However, most notified devices exempted from the clinical evaluation procedure met the same derogation requirement. Specifically, they all concerned modifications of a device already marketed by the same manufacturer with the same intended purpose, not negatively affecting the benefit-risk ratio.
Tables and Annexes in the CECP Report
The Report includes tables and annexes with following descriptions:
- Description of devices to which the CECP was applied.
- Description of medical devices exempted from the CECP.
- Listing of CECP applications where an opinion by the expert panels was delivered.
- Annex 1: Listing of notifications under Article 54(3) of the MDR – medical devices for which the CECP was applied.
- Annex 2: Listing of notifications under Article 54(3) of the MDR – medical devices
exempted from the CECP
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