UK Responsible Person
UK RP services for Medical Devices
As of Brexit, the Medicines and Healthcare product Regulatory Agency (MHRA) requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative for manufacturers of Medical Devices and will generally fulfil the same role. UKCA Experts, part of Certification Experts, will represent you as your UK Responsible Person (UKRP) in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). With over 25 years of experience, our team of 25+ experts will help you to obtain access to the UK market.
UK Responsible Person Medical Devices
Trust UKCA Experts to be your UK Responsible Person
What is a UK Responsible Person?
As of Brexit, the MHRA requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative for manufacturers of Medical Devices and will generally fulfil the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). They are a registered legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and the MHRA. Additionally, a UK Responsible Person service must include the provision of written evidence that they have the manufacturer’s authority to act as their UK Responsible Person.
What are the responsibilities of a Responsible Person?
There are a few UK responsible person requirements, including:
- Registering the manufacturer’s devices with the MHRA
- Ensuring that the Declaration of Conformity (UK DoC) and other technical documentation have been drawn up
- Verifying the conformity assessment procedure
- Making the UK DoC and technical documentation available for the MHRA
- Handling requests from the MHRA; providing them with samples, requested Documentation and information; and cooperating with them
- Cooperating with the MHRA to take preventive or corrective action with the purpose of eliminating or, if that is not possible, mitigating the risks posed by devices
- Informing the manufacturer if there are any complaints and reports from healthcare professionals, patients or users about suspected incidents related to their medical device
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body, of the termination
Lastly, it is important to know that the UKRP should be mentioned by name and address on the packaging (A UK responsible person symbol has not been issued by the MHRA), user instructions, or product labelling of your Medical Device as they function as your contact point for requests or concerns about your product. If your Medical Device is both CE and UKCA marked, this is still mandatory.
Who needs a UKRP?
As already stated, UKRP services have been made mandatory by the MHRA for manufacturers based outside of the UK who want to sell their Medical Devices, all classes (including Active implantable medical devices and In Vitro Diagnostic Devices), on the UK market. A UK responsible person is also used within cosmetics but AR experts does not act as a UK cosmetics responsible person.
Choose us as your UK Responsible Person!
MHRA UK responsible person medical device
MHRA is an abbreviation for Medicines and Healthcare product Regulatory Agency, sponsored by the Department of Health and Social Care. They regulate medicines, medical devices and blood components for transfusion in the UK. UKCA Experts ensured their MHRA UK responsible person registration in order to register the medical devices of our client. In the UK, devices must conform to the UK MDR 2002, the EU MDR (until 30 June 2023), or the EU IVDR (until 30 June 2023) in order to be registered with a UK responsible person MHRA. Additionally, devices that have been CE marked under the EU MDD, EU AIMDD or EU IVDD will continue to be accepted on the UK market until 30 June 2023 if their certificates remain valid for the EU market under the transitional arrangements in the EU MDR and EU IVDR.
The MHRA has made it mandatory for manufacturers of Medical Devices who are based outside of the UK but want to sell on the UK market, to assign a UK responsible person for medical devices. This UKRP needs to be based within the UK and must be registered on the MHRA registration system, meaning you need a MHRA UK responsible person. After being registered, the UKRP will then be able to start performing their designated tasks, including registering the device with the MHRA. A UK responsible person symbol has not been issued by the MHRA.
What is the procedure for UKCA Experts to become your UKRP?
After your request for authorised representation in the UK, we will send you a quotation on the requested services. Once you have accepted the quotation, we will start the documentation review together. In order to do this, one of our Compliance Experts will send you a link to a designated SharePoint environment to upload the technical documentation of the product(s) you want to place on the UK market.
Our team of experts will review the provided documentation and determine whether it is complete and meets the regulatory requirements for your product category.
Once it has been determined that the documentation meets the regulatory requirements, you will receive the UK responsible person agreement provided by our subsidiary UKCA Experts Ltd., which contains the mandate for Authorised Representation in the UK. UKCA Experts uses a ‘UK Responsible Person agreement template’, which is in compliance with the UK Legislation, to compile the obligated mandate. After both parties have signed the agreement, UKCA Experts Ltd. is officially your UKRP.
We will then register your product(s) in the MHRA system. Once approved by the MHRA, we will forward you the Registration Confirmation Letter.
It is good to know that once the mandate has been signed, the tasks that it claims are officially assigned to the RP, not only can but should be carried out by the RP from that moment forward. The manufacturer has outsourced that part of their responsibility and should no longer execute these tasks themselves.
AR Experts also provide the following Authorised Representation services:
- EU Authorised Representation
- UK Authorised Representation
- EC Rep for Medical Devices
Check out our UKRP services
Click on the service blocks to see our UKRP offerings
UK Responsible Person (UKRP)
As of Brexit, the MHRA requires manufacturers who are based outside of the UK to assign a UK Responsible Person (UKRP). A UKRP is essentially an Authorised Representative UK for manufacturers of Medical Devices and will generally fulfil the same role in accordance with the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR). They are a registered legal party based within the UK that acts as a liaison between a manufacturer outside of the UK and the MHRA. UKCA Experts (part of Certification Experts) act on behalf of a manufacturer established outside of the United Kingdom as their UKRP.
- Aid in UKCA marking conformity assessment procedure
- UKRP agreement/mandate
- Technical file and documentation review
- Acting as a contact person with the competent authorities
- Providing legal advice
- MHRA Registration
UKCA Declaration of Conformity
A UKCA Declaration of Conformity is an official document in which the manufacturer declares that their product is in compliance with the essential requirements of the applicable UKCA Statutory Instruments. This document is mandatory as it is necessary to be able to acquire UKCA marking. Certification Experts has both the knowledge and international experience to help you draw up a suitable UKCA Declaration of Conformity for your product, thereby ensuring that your product is safe and will be able to enter the market.
- Determine specific declaration of conformity requirements
- Determine applicable UKCA Statutory Instruments
- Collect all necessary product information
- Draw up the UKCA Declaration of Conformity
Mandate for Authorised Representation
AR Experts (part of Certification Experts) will set up the required mandate/agreement, herein it is determined which responsibilities/tasks of the manufacturer are mandated to the EUAR, UKAR, EC Rep and/or UKRP. This is based on the applicable directives and regulations.
- EU Authorised Representative agreement (mandate)
- UK Authorised Representative agreement (mandate)
- EC Rep agreement (mandate for medical devices)
- UKRP agreement (mandate for medical devices)
All the answers you might need!
Responsible Person UK services are for manufacturers based outside of the UK who want to sell their product on the UK market. For manufacturers of medical devices, having a UKRP is mandatory.
As of our knowledge there is no specific organisation or entity known as the “UK Responsible Person Association” that holds a widely recognised or established presence.
“UK Responsible Person MHRA” refers to the role of the UK Responsible Person as designated or defined by the Medicines and Healthcare Products Regulatory Agency (MHRA). This role is a legal requirement for manufacturers based outside the United Kingdom selling medical devices in the British market. The UK Responsible Person acts as an intermediary or representative for these manufacturers and ensures compliance with UK regulations.
A UK Responsible Person is responsible for all of the tasks that they and the manufacturer agree on, which are established in an official mandate.
The responsibilities include registering the manufacturer’s devices with the MHRA, ensuring the preparation of the UK Conformity Declaration (UK DoC) and technical documentation, verifying the conformity assessment procedure, providing the MHRA with necessary documents and information, collaborating with the MHRA for preventive or corrective actions to minimize risks, informing the manufacturer about complaints and reports of incidents, and terminating the legal relationship with the manufacturer if they fail to comply with regulations, reporting to the MHRA, and notifying the Notified Body if applicable.
A Responsible Person is a legal party based within the UK that acts as a liaison between a manufacturer of Medical Devices outside of the UK and competent national authorities within the UK. The RP takes on some of the manufacturer responsibilities, and makes sure that the devices being sold on the UK market comply with the relevant national compliance legislations. This way, safe and legal trade of your devices is guaranteed.
Under the UK Medical Devices Regulation (UK MDR), the “UK Responsible Person” (UKRP) is a requirement. Although there is no specific “UK Rep Symbol,” product documentation, labels, or packaging may need to include information indicating that a UKRP has been appointed to ensure that the manufacturer based outside the UK complies with UK regulations for medical devices. This could take the form of written information indicating the presence and role of the UK Responsible Person, rather than a specific symbol.
A manufacturer is free to assign any Responsible Person of choice. If you are looking for a suitable RP that will help you gain access to the UK market fast and efficiently, our experts with 25+ years of experience are happy to help.
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