Jurisdiction(s):
United Kingdom

Key definition

Medical device definition

What does Medical device mean? In legal practice, a medical device is a product intended by its manufacturer to diagnose, prevent, monitor, predict, treat or alleviate disease or injury in humans, or to investigate, replace or modify anatomy or a physiological process, whose principal intended action is not achieved by pharmacological, immunological or metabolic means (though such means may assist). It includes instruments, apparatus, appliances, implants, materials and standalone software, used alone or in combination. Reagents and related articles used with devices are covered; in vitro diagnostic items are regulated in parallel. The term is defined in legislation. In Great Britain, see the Medical Devices Regulations...

EU medical devices: legacy Directives regime—classification, conformity and CE marking, post-market surveillance and advertising, and transitional provisions for legacy devices to MDR/IVDR

Published by a LexisNexis Life Sciences expert

Practice notes

Practice Note

Within the EU, medical devices are strictly overseen by legislation that manages safety and performance throughout the whole lifecycle and across the full product lifetime, spanning pre- to post-market stages. This Practice Note outlines the regime established by Directive 93/42/EEC on medical devices (MDD), Directive 90/385/EEC on active implantable medical devices (AIMDD), which applied until 25 May 2021, and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD), which remained in force until 25 May 2022; collectively, the MD Directives. The MD Directives continue to matter for ‘legacy’ devices that were authorised under them for placement on the EEA market before the new rules started to apply. They will also persist as points of reference for several years for particular legacy devices, for differing durations, pursuant to transitional provisions. This Practice Note sets out how devices were categorised, subjected to conformity assessment, and affixed with the CE mark under the MD Directives. It further addresses advertising and promotion of medical devices, the issue of counterfeit medical devices, 3D printing, and mobile health...

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Jane Summerfield

Hogan Lovells

Jane Summerfield is Co-Head of our Life Sciences and Health Care sector and leads the Hogan Lovells life sciences regulatory and commercial practice in London. She advises life sciences companies on a wide range of regulatory matters, including clinical trials, early access, marketing authorisations, manufacturing and distribution licences, CE/UKCA marking, digital health, advertising and marketing activities, HCP compliance, and pricing and reimbursement. Jane also advises on commercial contractual arrangements, including consultancy, sponsorship, co-promotion, collaboration, manufacturing, distribution, services, quality and pharmacovigilance agreements. Jane works with clients to resolve issues with UK enforcement authorities and regulatory bodies, including the Medicines and Healthcare products Regulatory Agency (MHRA), Prescription Medicines Code of Practice Authority (PMCPA) and Advertising Standards Authority (ASA). Jane combines a scientific background with deep regulatory knowledge and a commercial approach, providing "clear responses with business impact"....

Fabien Roy

Hogan Lovells

As a partner of our Life Sciences practice, Fabien Roy focuses his practice at Hogan Lovells on advising Clients on European Union and national regulatory matters applicable to medical devices, medicinal products and combination products throughout their entire life cycle. With a practice entirely focusing on complex regulatory issues faced by Life Sciences clients, he can quickly address and anticipate complex challenges and propose innovative solutions enabling Clients to focus on their business. Fabien focuses particularly on guiding Clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures, conformity assessment and registration procedures and post-market activities. Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues...

Web page updated on 21/05/2026

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