UK Responsible Person
A UK Responsible Person is required for non-UK medical device and IVD manufacturers who place CE-marked or UKCA-marked products on the market in the UK.
Our UK Responsible Person Service
Patient Guard, with a registered office in the UK, offers UK Responsible Person services for non-EU medical device and IVD manufacturers. This service enables companies without a registered business in the UK to secure market access within the United Kingdom.
Benefits of working with Patient Guard
- Patient Guard ensures a simple and streamlined process.
- Patient Guard offers cost-effective services.
- Our team consists of highly qualified and experienced regulatory experts.
- Access the UK market with ease through Patient Guard.
- Rest assured your devices meet all regulatory requirements.
- Patient Guard is backed by professional indemnity insurance.
- Enjoy transparent pricing with no hidden fees.
Why Choose Patient Guard as your EU Authorised Representative?
Patient Guard proudly serves as the UK Responsible Person for over 30 medical device and IVD companies. These companies trust us to ensure their products comply with CE marking and UKCA marking regulations and are properly registered.
We simplify the process, making it smooth and hassle-free. Our qualified and experienced team is equipped to handle any queries and Post Market Surveillance (PMS) activities, including vigilance, with speed and efficiency. We ensure seamless communication between manufacturers and relevant authorities, keeping everything running smoothly.
Our Process
- A signed letter of designation is established between Patient Guard and the manufacturer.
- Patient Guard reviews the medical device or IVD technical documentation to ensure compliance with the Medical Device Regulations 2002 (as amended), Medical Device Regulation (MDR) EU 2017/745 or the In Vitro Diagnostic Regulation (IVDR) EU 2017/746, depending on which regulation is applied to your devices.
- Patient Guard requests the signed Medical Device or IVD Declaration of Conformity.
- If required, Patient Guard requests the CE certificate from a Notified Body for the medical device or IVD.
- Patient Guard registers the devices with the MHRA, the UK competent authority, through the MHRA registration database.
- Once approved, the manufacturer is authorized to sell products in the UK market.
Costs of Service
We offer a flat annual fee for our UK Responsible Person service, with no hidden costs or surprise fees. Unlike many other providers, you can add unlimited medical devices or IVD products for registration throughout the year where we will only charge you for the MHRA registration fee.
Getting started with UK Responsible Person Service
Get in touch to learn more about our UK Responsible Person service. We offer a free consultation where you can meet our team, discuss the process in detail, and share information about your company and products. After the consultation, we’ll provide you with a personalized quote and answer any questions you may have before you make a decision to proceed with our service.
UK Responsible Person - FAQs
Once the letter of designation is signed and we receive the required documentation, we review it within one week and proceed with registering the products. The entire process typically takes less than two weeks from start to finish. In rare cases, the process may take longer if authorities have questions about the medical devices or IVDs, though this has not been an issue in our experience so far.
No, only medical device manufacturers (CE mark or UKCA mark holders) without a registered business in the UK are required to appoint a UK Responsible Person.
Yes, it is legally required to include the UK Responsible Persons address and contact information on the labeling of medical devices or IVDs.
The UK Responsible Person conducts additional checks on medical devices manufactured outside the UK. They handle the registration of these devices with the MHRA and act as the communication link between the manufacturer and the MHRA for Post Market Surveillance and Vigilance activities, especially in the event of any incidents related to the device on the UK market.
The UK Responsible Person share joint liability for the medical devices they register and place on the market, making this a significant responsibility. This role includes handling administrative tasks throughout the year and managing any potential risks. Patient Guard also maintains high levels of indemnity and product liability insurance to ensure full protection.
Tracey Slater, Cormed
Find out more about medical device compliance and regulations
UK Responsible Person (UKRP) – Medical Devices
The UKRP must provide written evidence that they have the manufacturer’s authority to act as their UK Responsible Person. Importers
How to Structure a Medical Device Technical File
A medical device technical file is a concise set of documents created by a manufacturer to explain the performance and
Medical Device Consultancy – Patient Guard leads the way
Medical Device Consultancy provides tailored expertise to your business, helping to navigate the medical device industry.
With advancements in technology,
Regulating medical devices in the UK
When manufacturing medical devices for the UK market, you must be registered with the MHRA. They can help to ensure
Medical Devices Classification UK
In the UK Medical Devices are categorised into 6 classes, these are Class I, Class Is (sterile), Class Im (measuring),
