January 30, 2023
By Heather Crawford and Evangeline Loh
The European Commission (EC) published its first annual report about medical devices subject to the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) (EU) 2017/745. The report’s scope covers the time period between April 2021 and April 2022.
CECP and Notified Body requirements
According to the EC report, Notified Bodies (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. The EC introduces the term “ARMP devices” for such Class IIb devices. The CECP is intended to provide “independent scientific opinions by expert panels.”
A subtitle of this discussion could be the importance of the guidance MDCG 2020-13 on the clinical evaluation assessment report template (CEAR), as it is the NBs’ CEAR which is submitted in the CECP. Of course, the CEAR is generated after review of a manufacturer’s clinical evidence, read: the importance of the Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER).
The NB submits the CEAR and a justification as to whether the CECP is applicable (Article 54(3)). Exemptions to the CECP are delineated in Article 54(2). Note that MDCG 2019-3 provides guidance on CECP exemptions per Article 54(2)(b). It should be noted that even if the CECP is applicable, the expert panel determines if a scientific opinion is issued (Annex IX Section 5.1(c)).
MDR Article 54 reporting rules
The EC report addresses the requirement in MDR Article 54(4) to report annually on three categories: NB CECP applications and whether the CECP applies (Annex I) or devices are exempted from the CECP (Table 2, Annex 2); devices which 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 adhere to the counsel of the expert panel (section 4). There is detail about the type of devices which makes for an interesting review if you manufacture a Class III implantable or ARMP device.
EC CECP report findings
- Eight notified bodies reported 215 Class III implantable and ARMP devices; only 24 of these were subject to the CECP (11%).
- The majority of the 24 devices were Class III implantable (21, 87.5%) whereas 3 were ARMP devices (12.5%).
- Only six CECP applications required a scientific opinion (25%).
- Of the 191 Class III implantable and ARMP devices exempt from the CECP, 89% (170) were Class III implantable and 11% (21) were ARMP devices.
The scientific opinions from expert panels to the CECP are posted to the EC website.
For manufacturers with Class III implantable or ARMP devices these resources provide valuable information for their regulatory strategy related to MDR Article 54.
Heather Crawford is Lead Quality and Regulatory Affairs Consultant and Evangeline Loh is Global Regulatory Affairs Manager at Emergo by UL.