Medical devices and medtech

The medical devices sector is evolving at pace, driven by the convergence of software, AI, and connected hardware in everything from diagnostic platforms to implantable technology. Manufacturers and digital health innovators are facing a complex, growing web of regulation which spans UK and international medical device frameworks, data protection law, and emerging AI governance requirements. Our medical device lawyers help businesses, from early-stage spin-outs to established manufacturers, innovate, commercialise, and expand with confidence.

Comprehensive legal support from specialist medical device lawyers

We act for medtech, digital health, and AI-driven healthcare businesses at every stage of growth, from university spin-outs securing initial funding, through to established manufacturers managing international operations and expansion. Our experience spans the full commercial lifecycle of a medical device business, including regulatory advice on the classification of medical devices, software development, platform and distribution agreements, patents, and the clinical investigations and collaboration arrangements that underpin the development of products with academic and NHS partners.

Software-as-a-medical-device and AI-enabled platforms present distinctive legal challenges, particularly around data protection, AI governance, and intellectual property ownership. Our medtech lawyers regularly advise on the use of customer-contributed data and public datasets for machine learning, on securing ownership of generated IP, and on the privacy and end-user documentation needed for products used alongside a medical device. We assist with complex, multi-party arrangements involving universities, NHS bodies, and spin-out companies, giving us a practical understanding of the regulated, data-rich environments in which medical device innovation happens.

One of the go-to law firms for the biomedical community in the Oxford-Cambridge-London ‘golden triangle’.

As medical device businesses scale internationally, we support the corporate, governance, and operational infrastructure that growth demands. Our lawyers advise on growth funding rounds and further fundraising, from seed investment through to significant growth capital, as well as shareholder arrangements and company secretarial support.

As a full-service law firm, clients have access to joined-up advice, rather than siloed specialisms, which allows us to support businesses through funding rounds, strategic partnerships, and day-to-day operations and compliance, all with an understanding of the regulatory and commercial pressures specific to medical device businesses. Our medical device lawyers can also draw on specialist colleagues in employment, immigration, and real estate to support clients establishing teams, relocating talent, and securing premises as they expand into new markets.

How we help our clients

Manufacturing, testing, and development agreements for medical devices

Clinical investigations agreements, including CRO agreements

Regulatory advice and guidance, especially for software-as-a-medical-device (SaMD)

SaMD development and licensing agreements, including end-user terms and app terms for connected devices

SaMD platform distribution and reseller agreements

AI-as-a-medical-device advice on AI and machine-learning IP ownership and data licensing

Specialist data protection compliance, including DPIAs and transfer risk assessments

Collaboration and R&D agreements with universities and NHS bodies

Freedom to operate patent opinions for medical devices

Patent dispute resolution for metered dose inhalers, wearable technology and injectable devices

‘Green inhaler’ patent and changing NHS procurement criteria advice

Recent work highlights

Contracts and data protection compliance

Working with a UK and US based medtech company on its contracts and data protection compliance programme. Our medtech lawyers drafted app terms with an associated medical device, prepared policies, reviewed data protection audits, and input into data protection impact assessments.

Freedom to operate patent opinion

Providing a freedom to operate patent opinion for a pharmaceutical company in relation to the packaging of a reformulated medicinal product, including analysis of relevant patent rights, assessment of infringement risks, and strategic advice to support product development and commercialisation plans.

Documentation for digital health company

Drafting documentation for a UK-based digital health company for its BP and pulse measurement software, including end user documentation, advising on its distribution agreement and data protection implications, and coordinating local law advice in relation to a roll-out to another jurisdiction.

Digital health platform licences

Advising a digital platform supporting health and recovery on IP software and knowhow licences, and a separate R&D collaboration agreement to enable it to commercialise its technology, including rights needed in a further co-development licence.

AI medical device software regulation

Advising a medtech client on the regulatory aspects of its AI medical device software platform, enabling a Class I classification with the MHRA, and including drafting and negotiation of an AI system development and supply agreement.

Design right and patent protection

Advising on the availability and scope of design right and patent protection for an innovative GLP-1 agonist injectable product, including assessment of protectable features of the device, and guidance on securing IP protection in key markets.

Digital therapeutics commercial agreements

Assisting with key commercial agreements for a digital therapeutics company, including software development agreements, with a particular focus on securing ownership of all generated intellectual property.

AI healthcare spin-out company

Acting on the spin-out of an AI healthcare company. Our medical device lawyers advised on the licence of AI models, data, and code from the university and five other IP owners in a complex multi-party IP and licensing framework.

Vaccine development agreements

Acting for a vaccine development company on agreements for device development services and commercialisation of research results, involving medical device aspects for delivery of the vaccine.

Medical device AI intellectual property

Supporting on IP rights in AI projects, including AI systems within medical devices and data contributed by customers for machine learning and predictive analysis.

Digital therapeutics commercial agreements

AI healthcare spin-out company

Vaccine development agreements

Acting for a vaccine development company on agreements for device development services and commercialisation of research results, involving medical device aspects for delivery of the vaccine.

Medical device AI intellectual property

Supporting on IP rights in AI projects, including AI systems within medical devices and data contributed by customers for machine learning and predictive analysis.

Penningtons seems to be able to offer true value for money, with much hands-on involvement from knowledgeable and experienced partners with quality that is comparable to City law firms.

Penningtons Manches Cooper’s IT team is brilliant, reliable and responsive. The quality of service is outstanding.

A flair for the fine print of IP-rich transactions. No patent-related agreement is beyond its capabilities.

…very professional when advising us on the regulatory and compliance environment for our AI and machine learning solutions for the healthcare sector… delighted with the support and level of service we have received.