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Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA – New MORE Guidance on implementing the changing data requirements for medical device reporting

We have published new guidance to help medical device manufacturers prepare for changes to reporting requirements for serious safety incidents and field safety corrective actions in Great Britain. The new implementation guide for our Manufacturers Online Reporting Environment (MORE) clarifies the changing data requirements and timelines for compliance, before the new post-market surveillance regulations for medical devices come into effect on 16 June 2025. Please…
Ben Kemp
May 23, 2025
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 01 Jul)

Please note this is an extract of the original bulletin. Medical devices: UK approved bodies* Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Updated ‘DEKRA Certification UK Ltd medical devices scope’. *Note: IVD devices are not in scope Medical devices given exceptional use authorisations during the COVID-19 pandemic…
admin
July 10, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. Software and artificial intelligence (AI) as a medical device Page summary: Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). Change made: Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices…
admin
June 19, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 May)

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition. Change made: Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical…
admin
May 29, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 13 May)

Please note this is an extract of the original bulletin. MHRA announces dedicated new team to support the international community in tackling antimicrobial resistance Page summary: Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics…
admin
May 22, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 06 May)

Please note this is an extract of the original bulletin. Update on pioneering initiative on regulation and evaluation of digital mental health technologies Page summary: An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals. Change made: First published.…
admin
May 14, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 29 Apr)

Please note this is an extract of the original bulletin. Impact of AI on the regulation of medical products Page summary: Implementing the Artificial Intelligence (AI) White Paper principles. Change made: First published. MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030 Page summary: The MHRA has today set out its strategic approach to artificial intelligence (AI)…
admin
May 8, 2024
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made: Added: LNE-GMED UK Limited in-vitro medical devices scope. LNE-GMED UK Limited active implantable medical devices scope Notify MHRA about a clinical investigation for a medical…
admin
May 1, 2024
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