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 MDR/IVDR EUDAMED and UDI: compliance obligations for manufacturers, authorised representatives, importers and distributors, with roll-out timelines and transitional guidance

Published by a LexisNexis Life Sciences expert

Practice notes

This Practice Note explores the European database on medical devices (EUDAMED) and the obligations on economic operators, including manufacturers, distributors and importers of medical devices, arising under Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), and Regulation (EU) 2017/746, the In Vitro Diagnostic Medical Devices Regulation (IVDR). For guidance on:

key provisions of the MDR and IVDR, refer to Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation
scope and classification of devices, conformity assessment procedures and Notified Bodies, see Practice Note: The EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation—scope, classification of devices and Notified Bodies
clinical evaluation and investigation of devices, consult Practice Note: Clinical evaluation and performance evaluation of medical devices in the EU
post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU

EUDAMED and UDI system

The European Commission has been tasked with upgrading Eudamed2, the database created under the MD Directives regime, to encompass information about all devices and about their manufacturers, importers and authorised representatives. The initial plan was for EUDAMED to be accessible for use, even if not fully operational, from the date of application of...

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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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