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• Registering the manufacturer’s devices with the Medicines and Healthcare products Regulatory Agency (MHRA)
• Liaising with the MHRA on behalf of the manufacturer
• Ensuring that the manufacturer complies with all applicable UK medical device regulations

Responsibilities of the UKRP

The UK Responsible Person (UKRP)  has a number of important responsibilities, including:

• Ensuring that the manufacturer’s devices are registered with the MHRA before they are placed on the UK market
• Responding to requests from the MHRA and providing them with any information or documentation they need
• Forwarding any requests from the MHRA for samples or access to devices to the manufacturer
• Ensuring that the MHRA receives any requested samples or is given access to any requested devices
• Terminating their relationship with the manufacturer if the manufacturer fails to comply with its obligations
• Ensuring that the manufacturer’s devices comply with all applicable UK medical device regulations

Benefits of using a UKRP service

There are a number of benefits to using a UKRP service, including:

• Expertise: UKRP service providers have the expertise and experience to help manufacturers comply with all applicable UK medical device regulations.
• Convenience: UKRP service providers can handle all aspects of UK regulatory compliance on behalf of manufacturers, freeing up manufacturers to focus on other aspects of their business.
• Cost-effectiveness: UKRP services can be cost-effective, especially for manufacturers who do not have a presence in the UK.

How to choose a UKRP service provider

When choosing a UKRP service provider, manufacturers should consider the following factors:

• Experience: The service provider should have experience working with manufacturers of medical devices similar to the manufacturer’s products.
• Expertise: The service provider should have the expertise to help the manufacturer comply with all applicable UK medical device regulations.
• Track record: The service provider should have a good track record of helping manufacturers successfully place their products on the UK market.
• Cost: The service provider should offer competitive pricing.

The UKRP service is a critical partner for foreign medical device manufacturers who wish to market their products in the United Kingdom. By using a UKRP service, manufacturers can ensure that their products comply with all applicable UK medical device regulations and that they are meeting their regulatory obligations to the MHRA.

RABT Global is a leading provider of UKRP services. We have a team of experienced and knowledgeable professionals who can help you comply with all applicable UK medical device regulations and place your products on the UK market successfully. Contact us today to learn more about our UKRP services.