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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.

Backed up by our capabilities as a full-service law firm, we 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 relationships 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.

Find out more about our services and experience below.

Talk to us today by completing our contact form at the bottom of the page.

In this section

In this section

Our services & experience

  • Our services

    We can advise on:

    • 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.

  • Our experience

    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.

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