Jurisdiction(s):
United Kingdom

Related legal acts

Key definition

Monitoring definition

What does Monitoring mean? Monitoring, in radiological protection practice, is the measurement of ionising radiation levels, airborne concentrations of radionuclides, surface contamination and other quantities of radioactive material, and the use of those results to evaluate potential exposures and doses. The term is used and, in substance, defined in radiation protection legislation (including the Ionising Radiations Regulations 2017 in Great Britain, the Ionising Radiations Regulations (Northern Ireland) 2017, and Ireland’s regulations implementing the Basic Safety Standards Directive). In legal and compliance contexts, monitoring typically covers workplace monitoring, personal dosimetry, contamination surveys and environmental/discharge monitoring. It is undertaken to demonstrate compliance with dose limits...

EU MDR/IVDR post-market surveillance: manufacturer obligations, PMS plans, PSURs, vigilance, incident and trend reporting, field safety corrective actions, EUDAMED and UDI

Published by a LexisNexis Life Sciences expert

Practice notes

Post-market surveillance

Post-market surveillance refers to manufacturers’ ongoing oversight of medical devices to confirm they remain safe and effective for patients once authorised and placed on the market. Its aim is to detect whether corrective or preventive safety actions are needed. While the former regulatory framework under the medical device directives did impose compliance duties, it faced criticism for lacking rigour in tracking safety when products are actually used by patients, and for failing to feed that experience adequately into the official safety profile and continuing authorisation. The device scandals involving Poly Implant Prothése (PIP) breast implants in the early 2000s, followed by a widespread hip implant crisis that harmed hundreds of thousands of patients across multiple countries, exposed the shortcomings of a safety certification regime unevenly carried out by different Notified Bodies, and triggered a comprehensive overhaul of medical device regulation. A central element of Europe’s regulatory reform is stronger post-market surveillance Requirements. Notably, there is greater focus on gathering clinical and safety data after CE certification and market entry to prevent concealed defects or security risks. Devices must...

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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 27/05/2026

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