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

By Heather Crawford and Evangeline Loh

Second EC annual report published on medical devices subject to MDR CECP requirements

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.

CECP second report findings

• Thirteen NBs submitted 353 devices as deemed within the CECP scope, the NB involved determined that 36 (10.1%) of the devices were not exempted from the CECP.
• The majority of the 36 devices were Class III implantable devices (34, 94.4%) whereas two were Class IIb ARMP devices (5.6%).
• Of the 36 devices, the expert panels decided to provide an opinion on four of 35 (12%) applications received, with one application pending.
• The remaining 317 devices consisted of 285 (89.9%) Class III implantable devices and 32 (10.1%) Class IIb ARMP devices. The most common reason for exemption (314, 99.1%) was the modification of a device already marketed by the same manufacturer for the same intended purpose and the modifications not adversely affecting the benefit-risk ratio.

Scientific opinions from the expert panels to the CECP are posted on the EC website. The opinions are organized by the expert panels, the titles provide the date the dossier was submitted as well as the four-digit number of the NB involved.

Concluding remarks

The majority of scientific opinions rendered by the expert panels indicated limits in the currently available and planned clinical evidence, with recommendations to collect additional data.  No NBs submitted justification for a decision not to follow the advice of the expert panel in completing the certification process. 

The NBs value the opinions of the expert panels. These summary documents provide background on the manufacturer’s device as well as insight into the NB’s assessment and CEAR, as well as the review of the expert panel. Manufacturers of Class III implantable and ARMP devices subject to CECP should consider these opinions as input to their regulatory strategy, particularly regarding MDR Article 54.