GRS News

Background on UK Responsible Person (UKRP) Requirements

Following Brexit, the regulatory landscape for medical device companies selling in the United Kingdom has undergone significant changes. Manufacturers outside the UK must appoint a UK Responsible Person (UKRP) to place devices on the Great Britain market (England, Wales, and Scotland).

 

Role and Responsibilities of the UK Responsible Person

The UK Responsible Person acts on behalf of the non-UK manufacturer to ensure compliance with the relevant regulations. Key responsibilities include:

• Ensuring the declaration of conformity and technical documentation is prepared, and appropriate conformity assessments have been carried out.
• Keeping copies of the technical documentation, declaration of conformity, and relevant certificates for inspection by the MHRA.
• Providing the MHRA with necessary information and documentation to demonstrate device conformity upon request.
• Supplying samples or access to the device if requested by the MHRA.
• Communicate any MHRA requests to the manufacturer and ensure compliance.
• Cooperating with the MHRA on preventive or corrective actions to mitigate risks posed by devices.
• Informing the manufacturer of complaints and reports from healthcare professionals, patients, and users about suspected incidents.
• Terminating the relationship with the manufacturer and informing the MHRA if the manufacturer fails to meet regulatory obligations.

The UKRP’s name and address must be included on the product labelling where the UKCA mark is affixed, although this is not necessary for CE-marked devices.

 

Submitting Devices for Registration

Manufacturers should aim to appoint their UKRP as soon as possible. The UKRP must then register the relevant devices with the MHRA in line with specified grace periods depending on the device risk classification.

 

How Global Regulatory Services (GRS) Can Help

Global Regulatory Services (GRS) and Med-Di-Dia support your business in meeting these new regulatory requirements. With offices in the UK and Ireland, GRS and Med-Di-Dia can act as your UK Responsible Person (UKRP) and EU Authorised Representative (EU AR), ensuring seamless compliance and continued market access in the UK and the EU, including Northern Ireland.

Our services include:

• Acting as your UKRP and EU AR, ensuring compliance with UK and EU regulations.
• Managing device registrations with the MHRA.
• Liaising with regulatory authorities on your behalf.
• Providing expert guidance on regulatory requirements and updates.
• Ensuring your product labelling meets all requirements.
• and much, much more!

 

Contact Us

For expert guidance and support with your regulatory needs, contact our experts by visiting https://globalregulatoryservices.com/global-regulatory-services-contact-details or emailing us at grs@globalregulatoryservices.com

 

By partnering with GRS and Med-Di-Dia, you can confidently navigate the post-Brexit regulatory landscape and continue to successfully bring your medical devices to market.