MDR European Medical Device Importer Template


The European Commission in the Medical Device Regulations (MDR) has imposed many legal obligations on you the European Medical Device Importer. These legal obligations require you, an Importer, to maintain several registers which include, but are not limited to, Complaints, Device Verification, Class III implantable, and Vigilance registers, plus more.

Following direct industry requests, using their extensive MDR and EUDAMED experience, have prepared spreadsheet templates specifically for you the European Medical Device Importer. These templates will assist you in meeting your many importer legal obligations.


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