Conformity assessment: Annual report on Clinical Evaluation Consultation Procedures (CECP)

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 . . .

 

Oh! It looks like you do not have access to this page.
Find the membership plan that suits you, and within a few minutes you are good to go.
Are you a member already? Log in here.