Medical Devices

Multidisciplinary legal support to help guide your journey to market.

In this section

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.

Meet the team

Wide range of specialisms

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 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

Specialist 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.

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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

Claire Burrows

Partner

Richard Hough

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

Colin Bell

Partner, Head of Intellectual Property, Head of Technology Sector

Medical devices FAQs

Under the Medical Devices Regulations 2002, devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) before being placed onto the market. A ‘Responsible Person’ for marketing the device must be appointed under The Medical Device Regulations 2002.

Similarly, manufacturers placing a device on the GB market must register with the MHRA and pay the applicable fee.

If a manufacturer isn’t established in the UK, it must appoint a ‘UK Responsible Person’ to register and act on its behalf, including registering the manufacturer’s devices with the MHRA.

To register, companies must pay the relevant fee and provide the MHRA with various information about the device and manufacturer including:

Legal entity name and address of the manufacturer as it appears on the device labelling or packaging.
Company type and administrative contact.
Letter of designation for the UK Responsible person (if applicable).
Which legislation applies to the device.
Class, name, model, reference number and attributes of the device (such as sterility and/or ‘contains latex’).
UK Approved Body (where applicable).
Copies of any conformity assessment certificates of self-certification declarations, as applicable.

Depending on which legislation the device has been certified under, medical devices need a CE or UKCA marking, which must appear on the label. To obtain this marking, the product may need to undergo a conformity assessment by an Approved Body or Notified Body, whose number must also appear on the label.

The name and address of the UK Responsible Person (where applicable) must be included on the product labelling, outer packaging or instructions for use in cases where the UKCA marking has been affixed (including when devices have been dual marked).

Further information to be supplied — including what information must be included in the instructions for use and mandatory labelling information — is set out at paragraph 13 of Annex I of Council Directive 93/42/EEC.