Representation
EU Representative
For all legal manufacturers of medical devices not established in a European Member State, the device(s) may only be placed on the Union market if the manufacturer designates a sole Authorised Representative.
ALPA Medical, through its Italian office in Brindisi, provides EU Representative services as an Authorised EU Representative for medical device manufacturers outside Europe. Our role is defined by MDR Article 11; the manufacturer’s own obligations under Article 10 cannot be delegated to us.
What we take on
As your EU Representative, our responsibilities are to:
- Act only under a written mandate that covers all devices of the same generic device group, as the manufacturer’s sole Authorised Representative
- Verify that the EU Declaration of Conformity and technical documentation have been drawn up, and that the appropriate conformity assessment has been carried out
- Keep a copy of the technical documentation, the Declaration of Conformity and any certificates, including amendments and supplements, at the disposal of Competent Authorities for at least 10 years, and 15 years for implantable devices
- Register in EUDAMED and obtain a Single Registration Number (SRN)
- Keep our registered information up to date, and confirm the accuracy of the data after one year and every two years thereafter
- Verify that the manufacturer has met its device registration and Unique Device Identification (UDI) obligations in EUDAMED
- Provide Competent Authorities, on request, with all information and documentation needed to demonstrate the conformity of a device, in an official Union language
- Provide a copy of the mandate to the Competent Authority on request
- Forward any Competent Authority request for samples of, or access to, a device to the manufacturer, and verify that the authority receives them
- Cooperate with Competent Authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices
- Immediately inform the manufacturer of complaints and reports of suspected incidents from healthcare professionals, patients and users
- Terminate the mandate if the manufacturer acts contrary to the Regulation, and immediately inform the Competent Authority and, where relevant, the Notified Body, with reasons
- Maintain, permanently and continuously, a Person Responsible for Regulatory Compliance who is different from the manufacturer’s own PRRC
- Appear by name and address on the device label or instructions for use, and on the relevant documentation, as the European contact
- Accept joint and several liability for defective devices where the manufacturer is not established in the Union and has not complied with its obligations
- On any change of Authorised Representative, agree the arrangements with the manufacturer and the incoming representative, including dates and the transfer of documentation
- Cooperate with market surveillance activities, including making documentation available and accommodating announced and unannounced inspections
Get in touch
Need an EU Authorised Representative?
If you manufacture outside Europe, we can act as your sole Authorised Representative under the MDR through our Italian office in Brindisi.