The national guideline has been developed to assist sponsors of clinical investigations for medical devices in the management of these investigations in the context of the coronavirus pandemic.
The guideline addresses in particular the following points:
- initiation of new clinical investigations related to COVID-19;
- initiation of new clinical investigations not related to COVID-19;
- ongoing clinical investigations in Belgium.
For any other questions that are not covered in this document, please send your questions to firstname.lastname@example.org.