EU Authorised Representative

Every authorised representative signs the same Article 11 mandate and carries the same obligations. What differs is execution: whether the technical documentation is read during due diligence or after an authority asks for it, whether the person responsible for regulatory compliance sits inside the firm or is retained by contract, and whether competent authority correspondence is answered by the people who signed the mandate or passed to a subcontractor.

We hold manufacturer, importer and authorised representative registrations in EUDAMED and file UDI records for our own devices. All three are publicly searchable.