Overview of documents to be submitted for clinical investigations with medical devices

Publication | 18-05-2021

Review of a clinical investigation with a medical device – guidance document for MRECs

Publication | 17-05-2021

Appendix F. MDR and WMO relevant texts for assessment

Publicatie | 03-05-2021

Flow chart Adverse events in research with medical devices

Publication | 24-04-2021

B1a. Eudamed form

Below you can download the Eudamed form. Please use Appendix A to declare an additional medical device. Please use Appendix B to ...

Form | 21-04-2021

Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus

Publication | 23-02-2021

D2. IMDD template

Form | 14-12-2020

K3. Template Clinical Trial Agreement for investigator-initiated research for use with VGO

Form | 30-11-2020

K3. Template Clinical Trial Agreement for industry-sponsored research for use with VGO

Form | 30-11-2020

Flowchart Adverse events research with a medical device

Publication | 06-10-2020