According to Article 54 of the Medical Devices Regulation (MDR), Notified Bodies have to follow a Clinical Evaluation Consultation Procedure (CECP) when performing a conformity assessment of certain high-risk devices. In particular, this procedure applies to class III implantable devices and class IIb active devices intended to administer or remove a medicinal product (ARMP devices).
In January 2023, the Commission published the "Annual overview of devices subject to the clinical evaluation consultation procedure pursuant to Article 54 . . .
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