Medical device meaning

This Flowchart illustrates the typical lifecycle of a medical device The lifecycle outlines eight principal phases and flags relevant regulatory steps: (1) concept; (2) prototype design; (3) pre-clinical phase; (4) clinical phase; (5) manufacturing phase; (6) marketing; (7) commercial/patient use; and (8) obsolescence...

In this issue: Advertising, marketing and sponsorship Agency and distribution Consumer protection Contracts E-commerce International Public procurement Supplier management LexTalk®Commercial: a Lexis®Nexis community Daily and weekly news alerts New and updated content Dates for your diary Trackers Advertising, marketing and sponsorship ASA rulings—31 July 2024 The Advertising Standards Authority (ASA) has flagged the Person(s) unknown trading as Mendio Life for inquiry after insights from its Active Ad Monitoring system. A Meta promotion by Mendio Life for an acupressure clip asserted medical effects for a device lacking the necessary conformity marking and absent from the Medicines and Healthcare Products Regulatory Agency (MHRA) register. This decision sits within the ASA’s wider work on advertisements asserting treatment for prostrate issues, as part of a consumer-protection drive against such claims. The ASA also received a complaint about Nultqh GB’s Meta advert for a prostate patch, which advanced medicinal claims for an unlicensed item. The...

In this issue: Intellectual property Medical devices Pharmaceuticals—regulatory framework Borderline products Commercialisation Advertising of medicines LexTalk®Life Sciences: a Lexis®Nexis community Daily and weekly news alerts New and updated content Trackers Useful information Intellectual property Chris Weekes, Technical Assistant at D Young & Co, reviews a landmark ruling on infringement of a second medical use patent, indicating how the Unified Patent Court (UPC) may handle such claims. See News Analysis: First UPC infringement decision for second medical use claims. Medical devices MLex reports that the European Commission is weighing a delay to the EU AI Act entering into application amid disputes over a code of practice for AI models, mounting industry resistance, and slippage in drafting technical standards. The move, still unconfirmed, could pause enforcement timelines to allow targeted amendments aimed at simplifying specific elements. See News Analysis: EU Commission eyes pausing AI Act’s entry into application...

In this issue: Medical devices Data protection and life sciences Research and development Commercialisation Advertising of medicines Disputes and regulatory enforcement Daily and weekly news alerts New and updated content Dates for your diary Trackers Useful information Medical devices Government reaction to Whitehead Review on systemic bias in UK medical devices Harriet Hanks, counsel, Sanjana Canumalla, associate, and Matt Allison, trainee, at Freshfields Bruckhaus Deringer, examine and reflect on the findings of the Whitehead Review into equity in medical devices, published on 11 March 2024. See News Analysis: UK government responds to Whitehead Review’s findings of systemic bias in UK medical devices. Guidance on content of Investigator’s Brochure for clinical investigations of medical devices issued The Medical Device Coordination Group (MDCG) has published guidance on the Investigator’s Brochure (IB) for clinical investigations of medical devices (MDCG 2024-5). The document, grounded in Regulation (EU) 2017/745, the Medical Devices Regulation (MDR), is...

This Practice Note tracks key legislative and regulatory developments, government initiatives and strategies, and consultations relating to the use of artificial intelligence (AI) in life sciences and digital health in the UK. The rapid acceleration of AI within life sciences and digital health is spotlighting its power to transform research, fuel innovation and enhance patient care, whilst at the same time presenting intricate regulatory challenges. Across the UK, AI cuts across multiple established legal and regulatory frameworks, with the Medical Devices Regulations 2002 (MDR 2002), SI 2002/618 (as amended) being a central point of intersection. The UK Medicines and Healthcare products Regulatory Agency (MHRA) is advancing a suite of reforms to the UK medical device framework, with notable consequences for AI and digital health—particularly for Software as a Medical Device (SaMD), AI as a Medical Device (AIaMD) and cybersecurity expectations. See News Analyses: Life Sciences UK—key developments in 2025 and horizon scanning for 2026—AI and digital health UK medical devices regulatory reform—where are...

A–B | C–D | E–H | I–N | O–P. Qualified person (QP) The qualified person (QP) must confirm that every batch of medicinal products is manufactured and checked in line with UK or EU Member State law and in keeping with the marketing authorisation (MA) terms. See also: batch release marketing authorisation (MA) medicinal product Practice Note: Manufacturing of medicinal products for human use Qualified person for pharmacovigilance (QPPV) A qualified person for pharmacovigilance (QPPV) is the individual who, by law, holds personal responsibility for the safety of a human medicinal product. See also: adverse reaction marketing authorisation (MA) medicinal product Practice Note: Pharmacovigilance Rare disease See: orphan medicinal product (OMP)...

Failing to provide a specimen Under section 7 of the Road Traffic Act 1988 (RTA 1988), a person commits an offence if, when required to provide a specimen of breath, blood or urine for analysis, they fail to do so without reasonable excuse, whether they have driven, attempted to drive, or not. For detailed guidance on the requirement to provide a specimen, see Practice Note: Evidential specimens in road traffic cases. Failing to give permission for a laboratory test A separate offence arises where an individual supplies a blood sample but, without reasonable excuse, does not give permission for a laboratory test of that blood specimen. In those circumstances, they are guilty of an offence under RTA 1988, s 7(A)...

Introduction This medical devices regulatory due diligence questionnaire concerns the intended acquisition by [ insert buyer name ] (the Buyer) of the [ entire issued share capital of [ insert name of target company ] Limited, incorporated in England and Wales under number [ insert company number ] (the Company) OR [ insert description of the business to be acquired ] (the Business) as a going concern, together with specified assets employed in the Business ] from [ insert seller name ] (the Seller) (the Proposed Acquisition). The purpose of this questionnaire is to enable the Buyer, the Buyer’s solicitors and other professional advisers to secure essential legal information regarding the medical devices regulatory compliance of the [ Company OR Business ], which the Buyer requires to support the valuation of the [ Company OR Business ] and to assist with negotiating the Proposed Acquisition. Please respond to every question in full and accurately. Kindly set out your replies in italics directly beneath each question and supply copies of...