Most of a medical device distributor's apparent EU compliance gap is duplicate registrations. The real risk is in what is left over.

• EU distributors register with national authorities and in EUDAMED, the EU's device database, and the two often fail to match.
• Most mismatches are the same company registered twice, which is paperwork to tidy up.
• The real risk is a company named as importer, with an importer's legal duties for the devices, and no distribution business behind it.

• #due-diligence
• #eudamed
• #mdr
• #medical-devices