Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation

Posted on January 31, 2023 By MDSS In MDR, News

Understanding the Clinical Evaluation Consultation Procedure Under EU’s MDR Regulation

The EU’s Medical Device Regulation (MDR) has brought new requirements for the conformity assessment of high-risk medical devices. This regulation includes the implementation of the Clinical Evaluation Consultation Procedure (CECP) for certain class III implantable devices and class IIb active devices intended to administer and/or remove a medicinal product.

The CECP is an important procedure that provides independent scientific opinions on the clinical evaluation assessment report, which is critical for manufacturers to receive valuable feedback and improve their products. It’s essential for manufacturers to stay informed and compliant with the requirements of the MDR as it comes into effect.

From April 2021 to June 2022;

  • 215 notifications were sent by notified bodies (NBs) under Article 54(3) of the EU’s MDR.
  • 24 devices (11.2%) were subject to the CECP
  • While 191 devices (88.9%) were exempt from the CECP according to Article 54(2)b.
  • The experts screened 24 CECP applications and provided an opinion for 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’s 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.

Do you think the implementation of the CECP will have a positive impact on the medical device industry and the safety of medical devices?

 

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