Procedure for clinical trials
I am looking through the kit and I have not been able to find a procedure for clinical trials
Assign topic to the user
Yes, you are right. Unfortunately, in our toolkit there is no procedure for clinical trials because, in MDR 2017/745, requirements for documents for clinical investigation are very detailed described in Article 63, Article 72, and in Annex XV (Chapter II and III). Further on, clinical trials must be performed according to harmonized standard ISO 14155:2011 Clinical investigation of medical devices for human subjects — Good clinical practice. In most cases, clinical trials are conducted by specialized companies.
Which documents are necessary for medical devices you can find in the following material:
- EU MDR Checklist of Mandatory Documents https://info.advisera.com/13485academy/free-download/eu-mdr-checklist-of-mandatory-documents
Comment as guest or Sign in
May 27, 2020