UK REP

CMC Medical Devices offers UK Responsible Person (UKRP) for Medical Devices

We ensure that your products comply with all local regulations and are successfully launched in the British market. Since Brexit, manufacturers based outside the UK (including EU companies) are required to appoint a UK-based Responsible Person (UK RP) for their medical devices and in vitro diagnostic devices.

Responsible Person in the UK

Manufacturers who are not based in the United Kingdom must appoint a Responsible Person in the UK to assist the manufacturer in preparing for compliance with the UK medical devices market post-Brexit.

All medical devices, including in vitro diagnostic medical devices, must be registered anew; however, the MHRA has established different grace periods based on the product classification.

CMC Medical Devices UK is a subsidiary of CMC Group, located in London, United Kingdom. As a member of the Association of Responsible Persons in the UK, it has a professional international regulatory team and is qualified to act as the legal entity for manufacturers outside the UK. It maintains close communication and cooperation with authorities, assists in completing MHRA registration and UKCA certification, and performs manufacturer’s tasks in accordance with official instructions.

Our functions as Responsible Person in the UK

  • Register devices with MHRA
  • Ensure that technical documentation has been prepared.
  • Retain a copy of the technical documentation for inspection.
  • Cooperate and provide MHRA with all requested information.
  • Inform the manufacturer of complaints and incidents.
  • Represent the manufacturer.

Select CMC as your UK REP

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Frequently asked questions about UK Responsible Person

Since Brexit, manufacturers based outside the UK (including EU companies) are required to appoint a UK-based Responsible Person (UK RP) for their medical devices and in vitro diagnostic devices.

At CMC Medical Devices, we provide specialized representation and consultancy services for companies looking to enter the UK (Great Britain) market. With our deep understanding of regulatory requirements and extensive experience, we assist our clients in navigating UK regulations while ensuring the safety and compliance of their products. Our mission is to foster safer markets.

Furthermore, CMC Medical Devices is a member of the UK Responsible Person Association (UKRPA). Through this association, we work closely with the Medicines and Healthcare products Regulatory Agency (MHRA), enabling us to provide our clients with the most current regulatory updates in a timely and accurate manner.

Why appoint CMC Medical Devices as you UK-REP?

Fast response

We promptly and efficiently address any inquiries from authorities or regulatory bodies in the countries where we operate.

Efficient communication

Our team provides fast and clear responses to any questions or concerns, minimizing delays and ensuring a smooth approval process.

Immediate support

We handle inquiries and requests from both manufacturers and regulatory bodies with speed and precision.

Quick resolution

Any compliance questions or documentation needs are addressed promptly, ensuring your product moves through the regulatory process as quickly and smoothly as possible.

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