What is the role of a UKRP?
Medical device registrations and regulations are ever evolving so understanding how a UKRP can help has become a really important part of post-Brexit processes.
Making sure your products or medical devices meet the necessary quality management systems, documentation, and labelling standards is key to maintaining access to the UK market. This becomes even more significant with the introduction of the UK's Medical Device Regulations (aka MDR), where the role of a UK Responsible Person represents a cornerstone in compliance for both domestic and international manufacturers.
Post-Brexit Medical Device Regulations
Since January 2021, a few changes have been introduced through affecting medical devices in Great Britain (i.e. England, Wales, and Scotland). A new route to market and product marking, known as the UKCA marking, is now available. It's essential to understand that all medical devices, including in vitro diagnostic medical devices (IVDs), custom-made devices, and systems or procedure packs, have to be registered with the MHRA before being put on the market. If you are a manufacturer based outside the UK, appointing a single UK Responsible Person to handle registration and act on your behalf is a mandatory requirement.
Impact on Non-UK Manufacturers
For manufacturers not established in the UK, it's necessary to appoint a UK Responsible Person to register and represent your interests. Your UKRP carries out specific tasks such as making sure that your medical devices are registered with the MHRA before entering the Great Britain market, maintaining compliance, technical documentation and conformity assessments. Our primary role is to act on behalf of non-UK manufacturers to ensure that all medical devices are compliant before they are placed on the market in Great Britain.
Common Pitfalls We Have Come Across
Typical mistakes have included:
Incomplete Registrations: Failing to register your devices with the MHRA means you cannot legally market your products in Great Britain.
Outdated Documentation: Regularly update your technical documentation and conformity declarations. If things change, your documents need to change.
Misclassification of Devices: Incorrectly classifying your medical device can lead to wrong conformity assessments, which then leads to delay.
Successfully Navigating the Process
Navigating MDR and registering with MHRA can feel like a bit of a minefield, but remember, that’s what we’re here for. The first step you need to take is appointing a UK Responsible Person. It also helps to keep the lines of communication open with the MHRA. It’s also important to introduce robust post-market surveillance to monitor your devices' performance and safety continuously.
Working with the Right UK Responsible Person
When you're based outside the UK, your UKRP will handle all of the essential tasks such as registering your devices with the MHRA and ensuring that all necessary documentation and conformity assessments are properly managed. It's important to choose a partner who is not only knowledgeable but is able to maintain compliance, manage documentation, and interact effectively with the MHRA. For example, at Taylored Consultancy, we strive to build a strong and cooperative relationship is key. We are your voice in dealings with the MHRA and we work alongside you so that we know about any incidents, compliance updates, or changes in device specifications. A proactive approach mitigates risks and streamline the regulatory process.
Navigating the intricacies of the UK's post-Brexit medical device market requires a nuanced understanding of the UK responsible person requirements, our mission is to simplify your journey through the complex landscape of medical device regulations, ensuring smooth and successful market access in the UK and EU.
Are you ready to take the next step?
Get in touch today to learn how Taylored Consultancy can help you achieve regulatory compliance and market success.