For medical devices and in vitro diagnostic medical devices, after the United Kingdom (UK) leaves the European Union (EU), any UK-based Authorized Representative will no longer be recognized under EU law. This means they will not be recognized as able to carry out tasks on the manufacturer’s behalf for the purposes of placing products on the EU market. In order to place devices on the EU market, manufacturers with an Authorized Representative based in the UK will need to establish a new Authorized Representative in an EU country. This role is also called: UK Responsible Person.
This new role has been created under the UK MDR 2002 (as amended by the UK MDR 2019), which applies from the day the UK leaves the EU. The UK Responsible Person or UK AR, who must be established in the United Kingdom (UK), acts on behalf of a manufacturer established outside the UK to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the United Kingdom market.
What are the duties of an AR?
The UK Responsible Person / UK AR roles includes:
Provide a United Kingdom address to the Manufacturer
Documentation Device related check
Verify the Declaration of Conformity
Review the Technical Documentation
Check where applicable that an appropriate conformity assessment exists
Keep the previous documentation (UKCA, Declaration of Conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years or 15 years for implantable devices)
Record Retention and Document Control including version controls
Ensure Labelling is correct and includes the details of the Authorized Representative
Registration in United Kingdom
Communications with Health Authorities
As your UK AR (UK Responsible Person), RQMIS will:
Assist with Device Registrations within United Kingdom
Be identified on device product labeling throughout UK market
Make available to Competent Authorities (Medicines and Healthcare products Regulatory Agency (MHRA) and Notified Bodies) a current copy of the device Technical Document and/or UKCA, Declaration of Conformity for inspection, if requested
Assist the manufacturer and distributors with Incident and Field Safety Corrective Action reporting
Assist with Competent Authority communications
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