MDR requirements for pre-market clinical investigations – General considerations

 

A pre-market clinical investigation, namely, a clinical investigation with a device that has not yet been CE marked. MDR has come out quite additional requirement which were not there in MDD earlier.

MDR describes a set of technical and/or clinical requirements, aside from a typical, that gives a way of complying with the legal obligations applicable to a tool, process or system.’

The MDR sets out very detailed requirements regarding clinical investigations as compared with the Directives. MDR Articles 62 through 80 address: MDR requirement may look familiar as they are very similar to European harmonised standard BS EN ISO 14155-2011.

1. general requirements regarding clinical investigations conducted to demonstrate conformity of devices. Clinical investigation will have to comply with National competent authorities and Ethics committee. Sponsor requirement has also come. (Refer detail about sponsor and ethics committee requirement)

2.  Informed consent with relevant documentation.

3. Need for legal representative and competent authority approval.

4. clinical investigations on subjects requiring special consideration.

5. application process and assessment by Member States. If any SAE (Serious adverse event is reported, all member state need to be informed.

6. conduct of the clinical investigation and monitoring, and Monitors should be independent. Waivers are prohibited so plan must be made perfect.

7. GCP inspection by sponsors is needed. Audit by internal source or external body is needed.

8. QMS and Pre-Market clinical investigation. All elements of QMS must be considered.

9. Sponsor need to develop SOP relevant to clinical investigation.

10 Planning medical device clinical investigation. Revised BN ISO14155-2011 and ISO 14155 describes this process. Purpose must be defined and should be part of Planning.

11. Site selection

11. electronic system on clinical investigations and other aspects and data management is important for site.

Clinical investigation may also need to be conducted in stages (Refer ISO 14155 Annexe 1)

Regardless of its harmonization status, manufacturers are advised to get the quality as soon because it is out there and implement all applicable procedures and practices, because it will reflect the state of the art regarding good clinical practice (GCP) for medical device clinical investigations. Any references made during this blog post to the revised standard apply to the ultimate Draft of ISO/FDIS 14155 during which only editorial changes are often made before publication of the ultimate standard.

The European Commission is within the process of issuing guidance documents to assist in complying with the MDR, including clinical investigation requirements which can be available on the european Commission website.