UK Responsible Person
UKRP Service
At MDIN, we are qualified to offer our services as a UK Responsible Person for Medical Devices. As your chosen UKRP, we will undertake the following responsibilities:
- We will register your devices with the MHRA (Medicines and Healthcare Products Regulatory Agency).
- We will ensure that the necessary compliant Declaration of Conformity and Technical documentation has been properly prepared.
- We will retain a copy of the technical documentation so that it can be inspected by the MHRA whenever required.
- We will provide any requested information to the MHRA promptly.
- We will inform you about any complaints or incidents related to your devices.
- We will serve as your representative within the UK.
Starting from 1st January 2022, it has become a legal requirement (UK MDR 2002) for medical device manufacturers located outside of the UK to designate a UK Responsible Person (UKRP) who will act on their behalf when dealing with UK regulatory authorities. This appointment is necessary for these manufacturers to be able to sell their medical devices on the Great Britain market.
Are you ready to access the UK Market?
Why Choose MDIN to be your UKRP?
Comprehensive Regulatory Support:
Our team of seasoned consultants is here to dive deep into the world of UK medical device regulations, offering not just guidance, but a real understanding of the ins and outs. We make sure you’re always in the loop with the latest changes, helping you navigate the regulatory maze effortlessly.
Personalised to Your Business:
We get it – every business is different. We take the time to really get to know your unique needs, challenges, and goals. Our services aren’t one-size-fits-all; we tailor them to fit your specific needs.
We’re In it Together:
We believe in building strong relationships with our clients. No stiff, formal interactions here – we’re all about open communication and working together. Think of us as an extension of your team, offering ongoing support and advice to help you stay on top of your regulatory game.
Reviewing Your Regulatory Documentation:
Our skilled team takes a close look at all your technical documents – risk management files, labelling, and instructions for use. We ensure everything meets the standards set by UK regulations and point out areas that could need a little extra attention.
Selecting the right UK Responsible Person for Medical Devices is a crucial decision for manufacturers. Naturally, you want to collaborate with a reliable partner who can effectively represent you with the UK MHRA.
It can be advantageous to choose an independent entity that is not involved in any existing distribution or import relationships or contracts, to ensure that no routes to the market are jeopardised. By choosing MDIN as your UKRP, you satisfy both of these criteria.
Moreover, our services go beyond the basic responsibilities. We will keep you informed about any regulatory changes that could affect your business. Additionally, we will offer guidance on the regulatory pathway for obtaining the CE Mark or UKCA Mark, ensuring a smooth journey to market.
FAQs
UKRP services are for manufacturers that are based outside of the UK and who want to sell their products on the UK market. For manufacturers of medical devices and IVDs, having a UKRP is mandatory.
The UK Responsible Person, a legally designated entity situated in the UK, serves as an intermediary between a Medical Device manufacturer located outside the UK and the competent national authorities within the UK. Assuming certain responsibilities of the manufacturer, the UK Responsible Person ensures that the devices offered in the UK market adhere to the applicable national compliance legislations. This ensures the secure and lawful trade of your devices.
The UK Responsible Person is responsible for the following activities:
- Shall act on the foreign manufacturer’s behalf and register the devices with the MHRA before being placed on the UK market
- Shall ensure that all the device technical documentation and applicable declaration of conformity documents are in place for the device in scope and that the device manufacturer has completed the conformity assessment
- Shall maintain copies of the original, amendment and supplements of technical documentation, the declaration of conformity and certificates. These documents should be readily available in case of the MHRA inspections.
- Shall be able to present the documents that ensure conformity of the device
- Shall inform the foreign manufacturer immediately about the suspected incidents, complaints and reports received from healthcare professionals, patients and users
- Shall cooperate with the MHRA for any corrective and preventive actions taken for mitigation or elimination of any identified risks posed by the devices
- Shall either maintain samples or have access to the devices to provide to the MHRA on request. If not, UKRP shall forward the MHRA request for a sample or access.
- Shall terminate the agreement with the device manufacturer in case of non-conformities with applicable regulations
- Shall keep the MHRA and relevant Notified Body informed about the termination of the agreement, if applicable
Medical device manufacturers with already marketed devices in the UK should appoint a UK Responsible Person by 1st January 2021.
Device manufacturers that intend to place their devices in the UK market shall appoint a UKRP before the device is placed on the UK market. The UK Responsible Person shall register the devices with the MHRA.
Contact MDIN for a consultation. We will guide you through the steps of appointing us, including necessary documentation and compliance procedures.
MDIN offers personalized service, comprehensive regulatory support, and strong client relationships, ensuring seamless compliance with UK regulations.