Module 15 2022

19/05/2022

Implantable and class III devices

Modification to the manufacturer’s own device: Article 61.4 ● the device has been designed by modifications of a device already marketed by the same manufacturer ● the modified device has been demonstrated by the manufacturer to be equivalent to the marketed device, in accordance with Section 3 of Annex XIV ● demonstration of equivalence has been endorsed by the notified body ● the clinical evaluation of the marketed device is sufficient to demonstrate conformity of the modified device with the relevant safety and performance requirements ● PMCF plan must include post market studies

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

43

Implantable and class III devices Equivalent to another manufacturer’s marketed device : Article 61.5

● Requirements of 61.4 met: (equivalence, NB endorsed, CER sufficient) ● the two manufacturers have a contract in place that explicitly allows the manufacturer of the second device full access to the technical documentation on an ongoing basis ● the original clinical evaluation has been performed in compliance with the requirements of this Regulation ● the manufacturer of the second device provides clear evidence thereof to the notified body ● PMCF plan must include post market studies device.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 2

44

22