We will be working with importers / distributors for our product. Possibly we will be importer or distributor ourselves for some products in future.
When checking MDR obligations for economic operators they should (amongst other obligations) perform a verification of medical devices they handle.
I have clear what needs to be documented for the verification but what I do not have clear is whether this verification obligation applies
- to devices that ere CE-marked under MDD and MDR or
- to devices that are CE marked under MDR only
I highly appreciate your help, best regards,