The European Commission (EC) published its first annual report about clinical Evaluation Consultation Procedure (CECP) for the Medical Devices Regulation (MDR) (EU) 2017/745. This First Annual report’s scope covers the time period between April 2021 and June 2022.
What is Clinical Evaluation Consultation Procedure (CECP):
The Clinical Evaluation Consultation Procedure (CECP) is an important method that provides independent scientific opinions on the clinical evaluation assessment report. Because of this, Manufacturers will receive valuable feedback to improve their products as it is essential for them to stay informed and compliant with the requirements of the MDR since it comes into effect.
Notifications by notified bodies on whether or not the CECP applies:
As per EU MDR, a notified body (NB) shall follow a clinical evaluation consultation procedure (CECP) when performing a conformity assessment of certain high-risk devices, namely class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product (ARMP devices). The independent scientific opinions provided by expert panels on the NB’s clinical evaluation assessment report (CEAR) is based on the manufacturer’s clinical evidence.
For the Devices falling under the scope of Article 54 like Class IIb and Class III, the NB should send a notification to the competent authorities, as well as the authority responsible for notified bodies and the commission through Eudamed whether or not the CECP applies to a specific device as per the requirement set in Article 54 of the MDR.
According to Article 54(4) of the MDR, the Commission will draw an annual overview of devices that subject to the CECP, including:
- For all devices in scope of the CECP, a listing of notifications by NBs on whether or not the CECP applies;
- For all devices not exempted from the CECP, a listing of those for which the expert panels decided to provide an opinion;
- For all devices subject to an opinion from the expert panels, a listing of the cases where the NB did not follow the advice from the expert panel.
The first annual overview covers the relevant activities of the expert panels from their start date until 30 June 2022.
CECP Report findings and its Applicable Devices:
As per the EC CECP report findings from April 2021 to June 2022, the Notified Bodies has sent 215 Medical device notifications which constitute Class III implantable devices and Class IIb ARMP devices.
CECP applied Devices:
- Only 24 devices (11.2%) were subject to the CECP. The majority of the 24 devices, 21 were Class III implantable (87.5%) whereas 3 were ARMP devices (12.5%)
Exempted Devices from CECP:
- 191 devices (88.9%) were exempt from the CECP according to Article 54(2) b.
CECP applications leading to an opinion by the expert panels:
- The experts screened 24 CECP applications and provided an opinion for only 6 out of the 24 CECP applications received (25%).
- On June 30, 2022, 5 opinions were delivered by the expert panels, and one opinion was still under development. The secretariat did not receive any justification from NBs not following the advice provided by the expert panel.
The implementation of the CECP under the EU’s MDR regulation is a significant development in the medical device industry. It will bring higher levels of safety and quality to medical devices, ensuring that they meet the required standards. This will provide peace of mind to patients and healthcare professionals, who can rely on the safety and quality of medical devices.
In conclusion, it is crucial for manufacturers to stay informed and up-to-date with the requirements of the CECP under the EU’s MDR regulation. The CECP will play a critical role in ensuring the safety and quality of medical devices and provide valuable feedback to manufacturers.
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