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Ben Kemp

European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MDCG 2025-4 – Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)

Dear members, please see the new MDCG guidance regarding making available Medical Device Software, the guidance includes IVD software in scope. Note that this will also include provision of software via online platforms to Northern Ireland, as EU IVD Regulation also applies to Northern Ireland. MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New medical devices Post-market Surveillance regulations in force

New medical devices Post-market Surveillance regulations in force From today, new legal requirements for monitoring the safety of medical devices take effect, as part of our broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. Today’s reform applies to all UKCA- and…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Field safety notices: guidance for manufacturers

Field safety notices: guidance for manufacturers Page summary: How to write clear and effective field safety notices (FSNs) for medical devices. Change made: Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024. Time updated: 10:00am, 16 June 2025
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 16 June)

Borderline products: medical devices and other products Page summary: How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply. Change made: Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages. Time updated: 9:35am, 9 June 2025 Medical devices given…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department of Health and Social Care Updates (WC 6 June)

NHS red tape blitz delivers game-changing new cancer treatment Page summary: Patients to benefit from new era in cancer treatment, as Government slashes red tape to unleash life-saving innovation Change made: First published. Time updated: 4:09pm, 10 June 2025 Our vision for a new model of NHS care Page summary: The Health and Social Care Secretary spoke at NHS ConfedExpo…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Updates (WC 16 June)

Supplying authorised medicines to Northern Ireland Page summary: What you need to do to supply authorised medicines from Great Britain to Northern Ireland. Change made: • Added new overview section• Updated sections 2, 3 and 4 to reflect the implementation of the Windsor Framework on 1 January 2025 Time updated: 11:21am, 9 June 2025 Separation Agreement Joint Committee between the…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Business and Trade Updates (WC 16 June)

Employment Rights Bill: impact assessments Page summary: Impact assessments and analytical documents relating to the Employment Rights Bill. Change made: Number of small and micro business employees amended from 13 million to 9 million in ‘Employment Rights Bill economic analysis’ to mirror the figure used in the Summary Impact Assessment annex of the same document. Time updated: 3:13pm, 9 June…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Department for Environment, Food & Rural Affairs Updates (WC 16 June)

Foot and mouth disease in Hungary and Slovakia Page summary: Preliminary and updated outbreak assessments for foot and mouth disease (FMD) in Hungary and Slovakia. Change made: We’ve added an updated outbreak assessment for foot and mouth disease in Hungary and Slovakia for 5 June 2025. Time updated: 11:57am, 10 June 2025 Extended producer responsibility for packaging: recycling obligations and…
Ben Kemp
June 18, 2025
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