Medical devices

Copyright © 2025 LexisNexis

Overview Content for select subtopic is not present

Powered by Lexis+®
Latest Life Sciences News

MHRA opens second round of AI medical device regulatory sandbox applications

The Medicines and Healthcare products Regulatory Agency (MHRA) has announced the opening of applications for the second round of its AI Airlock regulatory sandbox programme, supported by £1m in new funding. The programme, which creates a supervised testing environment for artificial intelligence medical devices, implements commitments from the government's AI Opportunities Action Plan and response to the Regulatory Horizons Council report. Applications open 23 June 2025 and close 14 July 2025. The initiative is backed by the new Regulatory Innovation Office (RIO) to support more flexible regulatory approaches for emerging technologies.

Life sciences industry comments on the UK's Modern Industrial Strategy 2025

The UK Government has published its Modern Industrial Strategy 2025, outlining a 10-year plan to boost investment and productivity across eight key sectors, including life sciences. The strategy confirms that each sector will have a dedicated Sector Plan to provide specific detail, with the life sciences plan expected to align closely with the forthcoming NHS 10-year plan.

AIB and MDCG issue joint guidance on Medical Devices and EU AI Act requirements

The Artificial Intelligence Board (AIB) and Medical Device Coordination Group (MDCG) have published joint guidance (AIB 2025-1/MDCG 2025-6) clarifying the interaction between Regulation (EU) 2017/745 (Medical Devices Regulation (MDR)), Regulation (EU) 2017/746 (In vitro Diagnostic Medical Devices Regulation (IVDR)) and EU Artificial Intelligence Act (EU AI Act). The guidance establishes classification criteria for high-risk Medical Device Artificial Intelligence (MDAI), conformity assessment procedures, and requirements for data governance, human oversight and transparency. It outlines when MDAI systems require third-party conformity assessment and details post-market monitoring obligations. The document also clarifies substantial modification requirements and implementation timelines, with key provisions taking effect from 2 August 2027.

Changes to NDAs under the Victims and Prisoners Act 2024

Information Law analysis: The Victims and Prisoners Act 2024 (VPA 2024), section 17 comes into effect on 1 October 2025. The provision codifies common law protections for the reporting of crime to the police and whistleblowing in relation to criminal activity. It also expands the liberty of victims of crime to make certain further disclosures without risk of enforcement of non-disclosure agreements (NDAs). The scope of permitted disclosures includes those made for the purposes of seeking legal advice, co-operating with regulatory investigations and seeking support from certain persons in relation to the relevant conduct, which include, among others, victim support services, and the close family of the person making the disclosure. From 1 October 2025, contract terms seeking to prevent the making of such disclosures will be void and unenforceable. Written by Gaelyn Fuhrmann, solicitor at Wiggin.

View Life Sciences by content type :  
News
Practice notes
Precedents
Q&As

Popular documents

What is the difference between an appeal and a review?

What is the difference between an appeal and a review?What is an appeal?An appeal in insolvency proceedings is no different to an appeal in normal litigation. An appeal will be allowed only if the appeal court is satisfied that the decision of the lower court was 'wrong' or 'unjust because of a

Late payment penalties—inheritance tax

Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid

Contributory negligence in personal injury claims

Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a

Template for regulatory references given by SMCR firms and disclosure requirements

Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of
What is the difference between an appeal and a review?

What is the difference between an appeal and a review?

What is the difference between an appeal and a review?What is an appeal?An appeal in insolvency proceedings is no different to an appeal in normal litigation. An appeal will be allowed only if the appeal court is satisfied that the decision of the lower court was 'wrong' or 'unjust because of a

Late payment penalties—inheritance tax

Late payment penalties—inheritance tax

Late payment penalties—inheritance taxWhile interest often accrues on overdue tax, the late payment of certain taxes may also attract a penalty. For information on the interest accruing on overdue tax, see Practice Notes: IHT—payment deadlines on death—Interest on IHT and Interest on late paid

Contributory negligence in personal injury claims

Contributory negligence in personal injury claims

Contributory negligence in personal injury claimsContributory negligence is a partial defence which can lead to a discount in damages.Other defences may also be relevant. See Practice Notes: Did the claimant consent to the risk of injury? and Was the claimant involved in an illegal activity?If a

Template for regulatory references given by SMCR firms and disclosure requirements

Template for regulatory references given by SMCR firms and disclosure requirements

Template for regulatory references given by SMCR firms and disclosure requirements[Insert addressee details]Dear [insert name][It is our understanding that [insert name of prospective employee] [was an employee of yours between the dates of [insert dates as appropriate] OR is a current employee of