[Emergo, UL] Second Report on the European Clinical Evaluation Consultation Procedure (CECP)

The European Commission (EC) published its second annual overview concerning medical devices subject to the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) (EU) 2017/745. This is an update to the first CECP report (April 2021-June 2022). The current report summarizes activities of expert panels to the CECP from July 2022 through June 2023.

CECP and Notified Body requirements

The Notified Bodies (NBs) review the manufacturer’s clinical evidence and generate the clinical evaluation assessment report (CEAR, MDCG 2020-13).  NBs are required to follow the CECP when performing a conformity assessment of Class III implantable devices as well as Class IIb active devices intended to administer and/or remove a medicinal product (such Class IIb devices are referred to as “ARMP devices” in the report).

Unless otherwise exempted by Article 54(2), the CECP is intended to provide “independent scientific opinions by expert panels” based on the NB’s CEAR.  Note that MDCG 2019-3 provides guidance on CECP exemptions per Article 54(2)(b). 

MDR Article 54 reporting rules

These  annual overviews address the EC’s obligation (Article 54(4)) to provide annual reporting on devices subject to the CECP (references to the second report):

• NB CECP applications and whether the CECP applies (Annex I) or devices exempted from the CECP (Table 2, Annex 2)
• Devices that require the CECP and whether the expert panel provided a scientific opinion (Table 1, Table 3) and
• Devices from the group above, for which the NB did not adhere to the expert panel counsel (section 4)

Devices are identified by EMDN type with synopsis shared per category.

 

 

 

Second Report on the European Clinical Evaluation Consultation Procedure (CECP) | Emergo by UL

Second Report on the European Clinical Evaluation Consultation Procedure (CECP)

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