What is a UK Responsible Person and Why Do You Need One?

What is a UK Responsible Person?

A UK Responsible Person (UKRP) is your trusted partner in the United Kingdom, ensuring your products meet all necessary regulations. If your company is outside the UK and you want to sell medical devices, in-vitro diagnostic medical devices, laboratory instruments, or electrical equipment in the UK, you need a UKRP. We help you navigate the complex regulatory landscape, making sure your products are compliant and market-ready.

Why are They Important?

Since Brexit, the UK has its own set of rules for medical devices. As of January 1, 2021, manufacturers outside the UK must have a UKRP to sell their products here. This ensures that products are safe and meet UK standards. Having a UKRP provides you with a local point of contact, making it easier to manage regulatory requirements and communicate with UK authorities.

Our Services as Your UK Responsible Person

1. Ensuring Compliance: We make sure your products meet all UK regulations, checking that all necessary documents, like technical files and declarations of conformity, are accurate and up-to-date.

2. Product Registration: We handle the registration of your products (for medical devices with the UK Medicines and Healthcare products Regulatory Agency -MHRA), ensuring that all the required information is submitted correctly.

3. Ongoing Safety Monitoring: We keep an eye on your products once they are on the market, managing any reports of issues and coordinating any necessary recalls to keep your products safe and compliant.

4. Labelling and Instructions: We ensure that your product labels and instructions are clear, compliant, and in line with UK requirements.

5. Communication with Authorities: We act as the go-between for you and the MHRA, handling all communications regarding regulatory matters, product updates, and compliance issues.

6. Keeping Records: We maintain all your important documentation and regulatory submissions, ready for inspection by authorities whenever needed.

By partnering with us as your UK Responsible Person, you can confidently enter the UK market, knowing that your products comply with all necessary regulations. We provide the support you need to ensure safety, compliance, and smooth market access. Let us handle the regulatory complexities so you can focus on what you do best—delivering great products.