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Regulatory Affairs Newsletter Archive

UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 05 June)

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Reference guides and the videos ‘update devices and update products individually’ and ‘review and…
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June 16, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 05 June)

Please note this is an extract of the original bulletin. Health Infrastructure Plan: selection process for the next 8 new hospitals Page summary: The Department of Health and Social Care invited expressions of interests from mental health, community and acute NHS trusts who wished to be considered for inclusion in this next wave of the programme. Change made: Updated to…
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June 16, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

Formal stakeholder body created under the Health Technology Assessment Regulation

The Health Technology Assessment Stakeholder Network had its first meeting in Brussels on June 14th, where a formal stakeholder body under the Health Technology Assessment Regulation was created. There were representatives from stakeholder organisations and Member States in the Health Technology Assessment Coordination Group. This meeting was an opportunity to discuss the role of stakeholders in the implementation of the…
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June 16, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

EU Harmonisation of standards update

The European Commission's Directorate-General presented at the Medical Device Coordination Group (MDCG) – Subgroup meeting on Standards, held on 12 June 2023. The presentation and the meeting minutes will be published in the Register of Commission Expert Groups and Other Similar Entities, once approved by the members.
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June 16, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 05 June)

Please note this is an extract of the original bulletin. The Alan Turing Institute: Applying argument-based assurance to AI-based digital mental health technologies Page summary: Case study from the The Alan Turing Institute. Change made: First published. British Standards Institution: EU AI Act Readiness Assessment and Algorithmic Auditing Page summary: Case study from the British Standards Institution. Change made: First…
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June 16, 2023
Upcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Upcoming BSI Webinar: EU AI Act Explained: Navigating the new legislation with BSI

BSI are hosting a Medical Devices webinar on EU AI Act Explained: Navigating the new legislation with BSI. The EU Artificial Intelligence (AI) Act is a proposed European law on artificial intelligence the first law on AI by a major regulator. This webinar will look in detail at the EU AI Act, discussing the framework, the approach, the timeline, and the…
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June 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 29 May)

Please note this is an extract of the original bulletin. Human medicines: register of electronic export certificates Page summary: Department of Health and Social Care and MHRA register of electronic export certificates (human). Change made: Added Register of Electronic Export Certificates Issued by the MHRA (Human) – May 2023 PDF and XLS files Notify the MHRA about a clinical investigation…
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June 8, 2023
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