Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Lifecycle definition

What does Lifecycle mean? In legal practice, lifecycle describes the expected service life of an asset in a facility (for example, plant, machinery, fittings and equipment) during which it must meet contractual performance and statutory standards before planned renewal or replacement. It is a descriptive asset‑management term used across construction, facilities management, PPP/PFI/DBFM projects and leases, and is typically defined in the relevant contract rather than by legislation or case law. (By contrast, “life cycle” is referenced in public procurement rules for life‑cycle costing: Public Contracts Regulations 2015 (E&W and NI), Public Contracts (Scotland) Regulations 2015, and Ireland’s 2016 public authority contracts regulations.) Key legal...

EU MDR/IVDR clinical and performance evaluation of medical devices and IVDs: clinical investigations, evidence standards, risk management and post-market obligations

Published by a LexisNexis Life Sciences expert

Practice notes

Practice Note

This Practice Note sets out the principal updates to the mandatory clinical evaluation and performance evaluation pathways for medical devices under the EU regime brought in by Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR), together termed the MD Regulations. The MD Regulations represent a substantial shift in how the health and safety of devices are appraised, requiring a structured, rigorously evidenced clinical/performance evaluation that starts with the conformity process (CE marking) and carries on throughout the entire life cycle of a device. This Practice Note examines the practical consequences of the revised definitions and obligations for clinical data, clinical evidence and, notably, clinical investigations.

For further information on:

an introduction to the MD Regulations, see 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
post-market surveillance, see Practice Note: Post-market surveillance of medical devices in the EU
European database on...

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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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