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Medical Devices

Multidisciplinary legal support to help guide your journey to market.

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Our multidisciplinary, award-winning lawyers offer specialist legal advice and guidance on regulatory compliance for your medical devices.

Highly competitive and regulated fields like medical devices can be tricky to navigate and guarantee compliance and return on investment.

That’s why all economic operators involved in the manufacture, supply, importation and distribution of medical devices need a multidisciplinary and vastly experienced legal team to help guide their journey to market.

Whether you’re looking to understand and navigate complex regulatory requirements (including Brexit-driven dual regulatory regimes), receive expert representation at an inquest, register with the CQC (Care Quality Commission) or challenge regulators that have alleged legal obligation breaches, our deeply knowledgeable medical device and regulatory compliance specialists provide advice throughout the product life cycle.

Specialist regulatory compliance lawyers

Our team is led by specialist regulatory compliance lawyer Claire Burrows. Recognised by The Legal 500 and Chambers and Partners, Claire is a leading advisor on the complexities of placing medical devices on the market to ensure that they meet specific product requirements in respect of health and safety considerations, conformity testing and certification, technical file and labelling requirements. This means that products are fully compliant and regulatory liability is effectively managed in complex supply chains.

Claire is backed up by our capabilities as a full-service law firm, which enables us to provide advice across a wide range of legal specialisms, including corporate and commercial law, health, litigation, intellectual property and technology.

We have relationships with the ABHI (Association of British Healthtech Industries), AXrEM (Association of Healthcare Technology Providers for Imaging, Radiotherapy and Care), BDIA (British Dental Industry Association), Medilink North of England and MedTech Europe. These ensure that we stay up to date with the latest industry trends and best practice, as well as the challenges our clients are facing and what matters most to them.

The basics of CQC applications when setting up selling or purchasing a dental practice

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Legal advice for medical device and equipment compliance

We offer a full suite of legal services for your medical device product portfolio. 

Your needs might encompass:

  • Determining whether medical device regulations apply to products (and subsequent compliance obligations).
  • Technical file and certification documentation requirements, including third-party approved body certifications.
  • UKCA (UK Conformity Assessed) and CE marking requirements.
  • Correct product labelling, including details of manufacturers, importers and authorised representatives in the UK and EU.
  • Current extensions to the UK standstill period and the subsequent legal requirements when new legislation is revealed.
  • The role of economic operators in supply chains and subsequent obligations (as well as how to structure relationships to minimise obligations).
  • Contract specification requirements (for example, when engaging with suppliers).
  • Regulator engagement and enforcement actions.
  • Due diligence and post-completion corrective actions.

Expertise across compliance and regulation for medical devices

Our experienced medical device and regulatory compliance team helps clients across the medical device sector to navigate a wide range of legal and practical issues.

These include:

  • Medical and in-vitro medical device compliance and market placement in the UK and EU.
  • Changes to the regulatory landscape, including maximising the opportunities offered by transition periods whilst ensuring continued compliance.
  • Clearly delineating the legal obligations placed on economic operators in complex supply chains.
  • Importing and exporting medical devices.
  • Conducting and supporting internal investigations.
  • Liaising with (and challenging) regulators including the police, CQC, MHRA and HSE.
  • Licensing requirements for pharmacies and the possession and supply of controlled drugs.
  • Obtaining and maintaining relevant CQC registrations.
  • Representation during inquests.

Meet our medical devices experts

Richard Hough

Richard Hough

Partner, Head of Commercial & Intellectual Property, Head of Healthcare Sector

Colin Bell

Colin Bell

Partner, Head of Intellectual Property, Head of Technology Sector

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