The European Union requires any foreign manufacturer who intends to sell their devices in any of the Member States to designate a sole authorized representative with a physical address within one of the Member States.
What are the duties of an AR?
The role of an Authorized Representative in Europe is varied and challenging. The main duties include, but are not limited to, the following:
Providing a registered address within the European Union
Keeping all technical documentation available for inspection by the Competent Authorities
Completing notifications for the proper Competent Authorities
Completing any registrations in the national databases
Complete any Incident Reporting requirements
Represent the manufacturer towards the European Commission, Competent Authorities and/or Notified Bodies
Safeguarding and ensuring compliance with constant regulatory updates
Consulting on European Regulations
As your Authorized Representative, RQMIS will:
Assist with Device Registrations within the proper European countries
Proper identification on device product labeling throughout European market
Verify the Declaration of Conformity
Review the Technical Documentation
Check where applicable that an appropriate conformity assessment exists
Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years; 15 for implantable devices)
Make available to Competent Authorities (Ministries of Health, Notified Bodies) a current copy of the device Technical Documentation and/or CE Declaration of Conformity for inspection as requested
Immediately tell the manufacturer about complaints and reports from healthcare professionals, patients and users related to suspected incidents caused by their device.
Assistance with Competent Authority communications
Verify that the manufacturer is complying with the registration of the Unique Device Identification according to Article 27 (MDR) EU 2017/745.
Ensure the registration of the manufacturer, Authorized Representative, and importers are completed according to Article 31, (MDR) EU 2017/745.
In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language.
Keep the manufacturer informed of any request coming from the competent authorities.
Verify that the competent authorities receive the samples or is given access to the device.
Cooperate with the competent authorities for any preventive or corrective action taken to cut or mitigate the risks posed by devices.
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