To place a device on the Great Britain market (England, Wales and Scotland), manufacturers based outside the UK are required to appoint a UK Responsible Person. 

The UK Responsible Person must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers and distributors are not required to appoint a UK Responsible Person. 

Obligations of UK Responsible Person (UKRP)

1. Declaration of Conformity and Technical Documentation

Verify that the declaration of conformity and technical documentation are prepared and, if applicable, that the manufacturer has followed the appropriate conformity assessment procedure. 

2. Maintain Technical and Compliance Records

Keep a copy of the technical documentation, declaration of conformity, and any relevant certificates (including amendments and supplements) accessible for inspection by the MHRA. 

3. Provide Compliance Documentation

Respond promptly to MHRA requests by providing all necessary information and documentation to prove a device’s conformity. 

4. Device Samples and Access

If samples or access to devices are available, comply with MHRA requests to provide them. If not available, communicate MHRA requests to the manufacturer and relay the manufacturer’s response back to the MHRA.

5. Collaborate on Safety Measures

Work with the MHRA on preventive or corrective measures to eliminate or mitigate risks associated with devices.

6. Report Complaints and Incidents

Notify the manufacturer immediately of complaints or reports from healthcare professionals, patients, and users about suspected device incidents. 

7. Action Against Non-Compliance

If the manufacturer fails to meet regulatory obligations: 

• Terminate the legal relationship with the manufacturer. 

• Notify the MHRA and, if applicable, the relevant Approved Body about the termination. 

The UK Responsible Person’s name and address must be included on product labelling or packaging, or instructions for use with UKCA markings. CE marked devices don’t need details unless they have both CE and UKCA markings. 

Frequently Asked Questions: Responsibilities of UK Responsible Person

1. What is a UK Responsible Person (UKRP), and why is it required?

A UK Responsible Person (UKRP) is a legal representative for medical device manufacturers based outside the UK. They ensure that products comply with UK regulations before they are placed on the market. This role became necessary after Brexit, as the UK now has its own medical device regulations separate from the EU.

2. What are the main responsibilities of a UKRP?

A UKRP is responsible for:

• Registering medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA).
• Ensuring the manufacturer’s technical documentation meets UK regulations.
• Cooperating with the MHRA for compliance checks or investigations.
• Holding copies of key regulatory documents for authorities.
• Informing manufacturers about safety concerns or regulatory updates.

3. Can a distributor or importer act as a UKRP?

Yes, but only if they meet the regulatory requirements and formally take on the responsibilities of a UKRP. Some manufacturers prefer to appoint independent UKRPs to avoid conflicts of interest with distributors.

4. What happens if a UKRP fails to meet its obligations?

If a UKRP does not fulfill its duties, the MHRA can take regulatory action, which may include removing the medical device from the UK market. The manufacturer may also face legal consequences for non-compliance.

5. How can a manufacturer choose the right UKRP?

Manufacturers should look for a UKRP with expertise in UK medical device regulations, a good compliance track record, and clear communication processes. It’s important to have a formal agreement outlining responsibilities and expectations.