Clinical research involving the use of medical devices
A manufacturer is required to perform a clinical evaluation before being allowed to put a medical device on the market. A clinical investigation may form part of the clinical evaluation.
Legal requirements apply to the performance of a clinical investigation with a medical device that may not yet be marketed commercially for a specific purpose. The Inspectorate maintains supervision over compliance with this legislation.
The page explains how the Dutch Healthcare Inspectorate (DHCI) performs the supervision over clinical investigations involving the use of medical devices. This information is specifically meant for those who are involved in clinical investigations. If you are, please read this information carefully first. This should help to speed up the processing of notifications and questions.
- A: Relevant legislation
- B: Clinical investigations involving the use of medical devices – regime
- C: Mandatory notification of clinical investigations involving the use of medical devices
- D: Frequently Asked Questions about notification
- E: Reporting Serious Adverse Events
- F: Termination of clinical investigations involving the use of medical devices
If you have – after carefully reading the information presented on this website - any additional questions about clinical investigation involving the use of medical devices or the reporting of SAEs, you may contact the Inspectorate's information desk at firstname.lastname@example.org.