In-vitro diagnostic medical device meaning

In this issue: Medical devices Intellectual property Data protection and life sciences Pharmaceuticals—regulatory framework Research and development Competition in life sciences Daily and weekly news alerts New and updated content Trackers Useful information Medical devices Government supports new UK medical device rules following consultation The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the government’s concluding response to its consultation on planned updates to medical device legislation, setting out future pathways to market for medical devices. The government will advance three principal changes: adopting an international reliance framework, removing the UKCA marking requirement once devices carry unique device identification (UDI), and revising the classification of in vitro diagnostic (IVD) devices. Collectively, these measures are intended to modernise oversight while promoting innovation and protecting patient safety. See: LNB News 23/07/2025 14. AI developers, users see EU’s guidelines on general-purpose AI models MLex: On 18 July 2025, the European Commission released guidance...

In this issue: Medical devices Regulatory framework for medicinal products Data protection and life sciences Research and development Intellectual property Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices MHRA sets out its Roadmap towards updated medical device rules. Harriet Hanks, counsel, Andrew Austin, partner, Sofia Schaffgotsch, associate, and Honor May, trainee, at Freshfields Bruckhaus Deringer, examine the MHRA’s plans for the future regulatory framework for medical devices, released on 9 January 2024. See News Analysis: MHRA issues Roadmap towards new medical devices rules. Medical Devices (In Vitro Diagnostic Devices etc) (Amendment) Regulations 2024 SI 2024/221: made under legislative powers in the European Union (Withdrawal) Act 2018 relating to assimilated law. The Regulations amend three pieces of primary legislation, nine pieces of secondary legislation, and one piece of retained direct EU legislation concerning medical devices. They take effect from 21 March 2024. See: LNB...

In this issue: Commercialisation Pharmaceuticals—regulatory framework Medical devices Data protection Research and development LexTalk® Life Sciences: a Lexis®Nexis community Daily and weekly news alerts Useful information Commercialisation DHSC publishes response to NICE cost-effectiveness threshold consultation The DHSC has issued its reply to the consultation on proposed changes to the National Institute for Health and Care Excellence (NICE) rules on cost-effectiveness thresholds. Released alongside the National Institute for Health and Care Excellence (Amendment) Regulations 2026 and the accompanying explanatory memorandum, the amendments give ministers a narrow power of direction to set the standard cost-effectiveness threshold applied by NICE when preparing guidance, including technology appraisals and evaluations of highly specialised technologies. The revisions also remove the need for NICE to consult on procedural changes arising from ministerial directions. These measures will take effect on 24 March 2026. See: LNB News 04/03/2026 49. Pharmaceuticals—regulatory framework DHSC publishes fifth England Rare Diseases Action Plan 2026 The...

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,...

This Practice Note This Practice Note monitors the development of amending legislation, implementing acts, core guidance and initiatives introduced to help stakeholders apply the EU regime for medical devices and in vitro diagnostic medical devices (IVDs) contained in Regulation (EU) 2017/745 (the Medical Devices Regulation, MDR) and Regulation (EU) 2017/746 (the In Vitro Diagnostic Medical Devices Regulation, IVDR) (together, the MD Regulations) across all EU Member States as well as Norway, Iceland, Liechtenstein and Turkey. For a high-level overview of the MD Regulations and their obligations, see Practice Note: Introduction to the EU Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation. This tracker draws on material hosted on the European Commission—Public Health website—Medical Devices sector, comprising: guidance documents endorsed by the Medical Device Coordination Group (MDCG) MDCG guidance in progress the rolling plan of implementing measures under the MDR and IVDR (the rolling plan) the MDR/IVDR roadmap (November 2017), prepared by the competent authorities for medical devices project (CAMD)...

Developers, manufacturers and distributors in digital health—spanning mHealth apps and any associated Software as Medical Device (SaMD), artificial intelligence (AI) system or Artificial intelligence as a Medical Device (AIaMD)—must meet stringent data protection regulations in tandem with regulatory compliance across the entire lifecycle, from development through to commercialisation This Practice Note concentrates on data protection and privacy issues for mHealth (mobile health) and also considers the tighter safeguards governing the collection of an individual user’s health data. It does not cover broader life sciences regulatory matters, such as those relating to medical devices What is mHealth? For related guidance, see: Practice Note: Digital health—regulation of mHealth apps and medical software. Practice Note: Mobile app development and data protection. Practice Note: Digital health—data protection and privacy case studies, including wearables and AI diagnostic tools...