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 and IVD Regulations: placing devices on the EU market, transitional provisions for legacy devices, EUDAMED roll-out, Notified Bodies, and recent amendments (2023/607, 2024/1860)

Published by a LexisNexis Life Sciences expert

Practice notes

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This Practice Note summarises Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR), along with the steps for placing a device on the EU market, including how the intricate transitional rules apply to ‘legacy’ devices certified under the former directives system

For fuller analysis of how the MD Regulations affect related topics, see the following Practice Notes:

The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
Clinical evaluation and performance evaluation of medical devices in the EU
Post-market surveillance of medical devices in the EU
The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—EUDAMED and economic operators
The EU MDR and IVDR implementing acts and guidance tracker
Medical devices—UK and EU regimes comparison

Legislative framework EU Directives

Up to 25 May 2021, medical devices and active implantable medical devices (AIMDs) within the EU/EEA were governed by the...

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Alison Dennis

Taylor Wessing LLP

Alison co-heads the international Life Sciences and Healthcare group at Taylor Wessing. She works with international life sciences companies to cut through the complexity of EU regulation of medical devices and pharmaceuticals and get their products to market.In a career of over 20 years, Alison has helped hundreds of life sciences companies manage the range of legal challenges involved in commercialising medical devices and medicinal products. She combines an encyclopaedic knowledge of the EU and UK life sciences regulatory environment with an analytical understanding of strategy and business in the life sciences sector. Alison provides sophisticated advice on regulation, compliance and commercialisation, as well as intellectual property transactions. On a number of occasions, she has successfully persuaded regulators and notified bodies to reconsider and ultimately overturn their decisions, allowing her clients to commercialise new products.Alison supports clients on outright...

Web page updated on 21/05/2026

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