UK Responsible Person Services for MDR
Your Taylored Solution to
UK Medical Device Regulations
The Vital Role of the UK Responsible Person
Under the UK MDR 2002, the UK Responsible Person (UKRP) plays an important role in ensuring the compliance and safety of medical devices within the UK marketplace.
If you're a medical device manufacturer outside the UK wanting to sell in Great Britain, you must appoint a single UK Responsible Person for all your devices.
Taylored Consultancy Ltd provides comprehensive UK Responsible Person (UKRP) services to ensure your company and products comply with UK MDR 2002.
We understand the complexities of navigating Medical Device Regulations
UK Responsible Person Requirements
The UK MDR 2002 outlines the duties of the UK Responsible Person. In brief, besides registration, the UK Responsible Person must:
Ensure the manufacturer has prepared the declaration of conformity and technical documentation, and carried out appropriate conformity assessment
Keep copies of technical documentation, declaration of conformity, and relevant certificates for MHRA inspection
Provide the MHRA with information and documentation to prove device conformity when asked
Comply with MHRA requests for device samples or access, if available
If samples or access aren't available, relay MHRA requests to the manufacturer and inform MHRA of the manufacturer's response
Work with the MHRA on actions to reduce or eliminate device risks
Promptly inform the manufacturer about complaints and incident reports from healthcare professionals, patients, and users
UKRP Responsibilities
Regulatory Requirements
Appointing a UK Responsible Person is required for medical device manufacturers who are looking to import their products into the UK. The MHRA only accepts device registrations from UK-based manufacturers.
Compliance Check
We'll send you a 'UKRP Checklist' asking for documents to review. This ensures products for MHRA registration comply with UK MDR 2022. If we spot gaps, we can help create missing documents before registration.
Product Registration
We'll then register the devices in the work scope. Once the MHRA approves, we'll let you know so you can start or continue selling.
Ongoing Compliance
Once your product is on the market, we are here to ensure that your medical devices remain compliant. We stay up to date with any legal or regulatory changes, respond to any requests from authorities, provide necessary documentation, and demonstrate conformity on your behalf.
Why Would You Want to Work With Us?
We don’t just say we’re innovative, we prove it
At Taylored Consultancy, we create ‘taylored’ solutions, enabling you to launch your product in your desired market. Our innovative thinking ensures all projects are future-focused and support your company's expansion.
Our co-ordinated approach keeps you on track
We pride ourselves on our organisation and clear communication with clients. We provide clear project timelines, deliverables, and visibility on progress.
Licensed, Certified, and Experienced
Our experienced team offers expert advice to meet your regulatory requirements. We stay up-to-date with regulations and provide insights into future changes or amendments.
We work with you, alongside you, as part of your team
We work closely with your company to ensure our solutions are integrated across all functions. Regulatory projects can often work in silos, but we ensure seamless implementation that benefits all departments.
Find Out More
We'd love to hear from you. Whether you have questions about our services or need specific regulatory advice, our team is here to help.
