Brexit – Medical Device, IVD, & Pharmaceutical Services

On December 31st 2020, the UK officially left the EU single market. While there was a period of regulatory uncertainty, there is more clarity now as the Medicines and Healthcare products Regulatory Agency (MHRA) is the sole authoritative body for pharmaceutical and medical device products.

With its presence in the UK (London), Celegence can support all of your Pharmaceutical, In Vitro Diagnostic, and Medical Device regulatory needs. Additionally, if your organization is looking to maintain your market presence in the UK without a local office, we can act as your UK Responsible Person.

The Burden of Brexit on the Medtech Industry

Our team has kept up to date with the regulatory changes that Brexit has brought on since the initial date of effectivity back in March of 2019. We offer a range of services to ensure your company’s continued compliance in the UK. To read further about the implications of Brexit on the Medical Device Industry, you can download our White Paper titled The Burden of Brexit on the Medtech Industry


Similar to our EU MDR services, we can ensure every component of your documentation is compliant with the MHRA standards. Whether you are looking to bring your products to the UK market for the first time, or are looking to maintain your market access, we are here to help.

How Celegence Can Support Device and Pharmaceutical Manufacturers:


• UK Responsible Person Services
• Submission and Registration Support to the MHRA
• Technical Documentation Creation & Updates<
• Post Market Surveillance
• UKCA Mark Strategy Support (New UK Conformity Assessment Route)
• Support MAH (Marketing Authorization Holder) transfers

UK Responsible Person Services for Device Manufacturers

There are a number of responsibilities bestowed upon the UK Responsible Person to maintain compliance in the post-Brexit environment:

  • They must ensure the declaration of conformity and the technical documentation are sufficient, as well the conformity assessment procedure.
  • Keep a copy of the declaration of conformity, technical documentation, and any other necessary certificates on file for review by MHRA.
  • Respond to any queries or requests from the MHRA.
  • Facilitate any access to samples if requested by the MHRA.
  • Liaise with the MHRA relating to any preventive or corrective actions.
  • Ensure that the manufacturer is aware of any complaints or reports from patients, users, and healthcare professionals relating to the device.

  • Terminate the legal contract if the non-EU manufacturer does not adhere to their legal responsibilities and inform the MHRA and Notified Body if applicable.

Contact Us

If you’re curious how Celegence can help you with Brexit regulations, reach out to us and one of our team members will get in touch with you.

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