I am preparing an application to conduct a clinical study in Belgium (for the first time!). We have the application form, and thanks to a previous thread I found this website, which confirms the requirements.
I'm confused by the requirement for a declaration of conformity:
We do DoCs for our CE marked products, but I have never written one for an investigational product. This is an early feasibility study, so there are a lot of areas in which we do not conform.
Anyone done this before? Any recommended formats, etc.? Should I append our ER checklist to show where we conform and where we don't?
Any suggestions would be much appreciated!
Thanks,
Jen
I'm confused by the requirement for a declaration of conformity:
...declaration showing that the device meets the essential requirements except for those aspects covered by the clinical study, and showing that, concerning those aspects, every precaution has been taken to protect the health and safety of the patients
Anyone done this before? Any recommended formats, etc.? Should I append our ER checklist to show where we conform and where we don't?
Any suggestions would be much appreciated!
Thanks,
Jen