For medical device manufacturers located outside the United Kingdom (UK) without local business offices, it is mandatory to designate a United Kingdom Responsible Person (UKRP) to represent them. This designation is a prerequisite for registering and launching devices in the UK market. The UKRP, either an individual or a UK-based company, takes on this role on behalf of the manufacturer. This regulation applies to all classes of medical devices, including Active Implantable Medical Devices and In Vitro Diagnostic Devices.
The specifics of appointing a UKRP, their responsibilities, and related information are outlined in the UK MDR 2002. For those intending to introduce devices into the UK market, a UKRP should be appointed prior to device registration. The UKRP is responsible for registering devices with the MHRA (Medicines and Healthcare products Regulatory Agency).
An appointed UK Representative can be a third-party entity, importer, or distributor acting on behalf of a foreign manufacturer. The designated UKRP must also register with the MHRA.
All details about the UKRP's responsibilities are available on the MHRA website and the SI- MDR 2002. The duties of a UKRP include:
Registering devices with the MHRA before they are placed in the UK market
Ensuring all necessary technical documentation and conformity declaration are
Maintaining copies of relevant documents for MHRA inspections
Presenting documents confirming device conformity
Reporting incidents, complaints, and healthcare professional feedback to the manufacturer
Cooperating with the MHRA for risk mitigation actions
Maintaining device samples or access for MHRA requests
Terminating agreements in case of non-compliance
Informing the MHRA about agreement termination
The UKRP's details, such as name and address, should appear on the labeling, outer packaging, and instructions for use of all medical devices and IVDs marketed in the UK. It's important to note that either CE or UKCA mark are required for placing products in the UK market.
While maintaining a Quality Management System (QMS) is not mandatory, having a basic QMS in place is recommended for efficient compliance with the MHRA's requirements.
Manufacturers can switch their UKRP, but they need to inform the MHRA and follow specific procedures. Distributors and importers can also serve as UKRPs.
Selecting the right UKRP is a crucial step in launching devices in the UK market. Manufacturers need to consider factors such as the UKRP's registration status, capabilities, qualifications, and responsiveness. They should also ensure the UKRP is equipped with the necessary documentation templates and understands the regulatory landscape. The agreement between the manufacturer and UKRP should be documented and followed carefully.
As the transition period for UKCA marking is in effect, labeling requirements depend on the marking used. Manufacturers are advised to align with MHRA guidelines and ensure compliance. Timing varies based on several factors, but a reasonable pace could result in the entire process taking about two weeks.
Remember, a well-prepared and knowledgeable UKRP can greatly assist in successful market placement and maintenance of medical devices in the UK. Whether you're a medical device manufacturer, distributor, or importer, we're here to help you navigate the UK market with confidence. Don't miss out on this opportunity, contact Artixio Today!