Module 15 Presentations

10/04/2024

MDCG 2021-08

Clinical Investigation application/notification documents MDCG 2021-08 sets out guidance to be followed in the absence of EUDAMED. The application/notification documents associated with MDCG 2021-08 have been created to support Clinical Investigation procedures with respect to the MDR, are as follows: • Clinical investigation – application/notification form under the MDR • Addendum to the clinical investigation application/notification form for:

 Additional investigational device(s)  Additional comparator device(s)  Additional investigation site(s)

• Clinical investigation supporting documents - Appendix of documents to attach • Checklist of general safety and performance requirements, Standards, common specifications and scientific advice

The Organisation for Professionals in Regulatory Affairs

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CHAPTER VII POST-MARKET SURVEILLANCE, VIGILANCE AND MARKET SURVEILLANCE

Post-Market surveillance (Art 83-100)

For each device, manufacturers shall plan, establish, document, implement, maintain and update a post-market surveillance system in a manner that is proportionate to the risk class and appropriate for the type of device. That system shall be an integral part of the manufacturer's quality management system referred to in Article 10(9). The PMS system will be suited to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout it’s entire lifetime, drawing conclusions determining, implementing, monitoring and preventative and corrective actins.

The Organisation for Professionals in Regulatory Affairs

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