Welcome to UKRepMed, your trusted source for UK Responsible Person services. In this page, we will explain what a UK Responsible Person is, why it is essential, and how our services can benefit you.
A UK Responsible Person (UKRP) for medical devices is a person or company established in the United Kingdom who acts on behalf of a manufacturer based outside the UK to ensure that their medical devices comply with UK regulations. This role became essential after Brexit, as non-UK manufacturers can no longer sell medical devices directly into the UK market without appointing a UKRP..
Placing medical devices on the UK market requires full compliance with national regulations. For manufacturers outside the UK, appointing a UK Responsible Person (UKRP) is a legal requirement under the UK Medical Devices Regulations 2002 (SI 2002 No. 618, as amended).
At UKRepMed, we provide expert UKRP services to ensure your devices meet all UK regulatory obligations and can be sold confidently in the UK.
1. Legal Compliance
We ensure your device:
Meets relevant conformity assessment procedures.
Has a valid Declaration of Conformity (DoC).
Bears the correct UKCA or CE mark (where permitted).
Has full technical documentation available for MHRA inspection.
“The UK Responsible Person must act on behalf of the manufacturer to carry out specified tasks…” — Regulation 7A(1)
2. Device Registration
We register your devices with the MHRA via the Device Online Registration System (DORS), ensuring full compliance before market entry.
3. Safety and Vigilance
As your UKRP, we:
Report safety concerns, complaints, and incidents to you.
Liaise with the MHRA on corrective actions.
Support post-market surveillance (per Regulation 7A(4)).
4. Labelling
Your product labelling must include the name and UK address of your Responsible Person, providing a clear contact point for authorities and end users.
5. Recalls & Corrective Actions
In case of recalls or safety issues, UKRepMed coordinates directly with the MHRA to manage notices and minimise risk—protecting patients and your brand.
At UKRepMed, we offer comprehensive UK Responsible Person services tailored to your specific needs. Here’s how our services work:
Assessment: We start by evaluating your product and business to determine the scope of responsibilities required.
Feedback: If all your documents are in order, we can move on to the next step of the process
If your documents aren’t in order, we will provide guidance helping you to understand the requirements and get your documents in order
Quote and Contract: We will quote for the UK Responsible Person Service, including registration (where applicable) and send you the contract to be signed
Set up: Once the contract is signed, we will begin the set-up. This includes registration, assisting with updating labels and creating your file within our system.
Completion: Once the set-up is completed and your labels are updated and compliant, you are free to sell on the UK Market
On-Going Service:
Documentation: We assist in preparing and maintaining the necessary documentation, such as technical files and compliance reports.
Quality Control: We ensure that your products meet the highest quality and safety standards through regular inspections and risk assessments.
Market Surveillance: Our team monitors the market to identify potential issues and initiates prompt actions when necessary.
Reporting: We keep you informed with detailed reports on product compliance and any regulatory updates.
Emergency Response: In the event of recalls or safety concerns, we coordinate and manage the necessary actions to protect consumers and your business.