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Regulatory Affairs Newsletter

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

DBT weekly update (WC 27 Nov)

Please note this is an extract of the original bulletin. Advanced manufacturing plan Page summary: The advanced manufacturing plan sets out the actions we are taking to be the best place in the world to start and grow a manufacturing business. Change made: First published. UK battery strategy Page summary: The UK battery strategy sets out the government’s vision for…
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December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 27 Nov)

Please note this is an extract of the original bulletin. Data Protection and Digital Information Bill: supporting documents Page summary: Supporting documents assessing the impact of the Data Protection and Digital Information Bill. Change made: Added the DWP third party data impact assessment to the list of supporting documentation. Research and Innovation Organisations Infrastructure Fund Page summary: Fund for improving…
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December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Nov)

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: Clarification concerning fees and actions required to change legislation of a registered device. The…
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December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 27 Nov)

Please note this is an extract of the original bulletin. New research into expansion of life-saving HIV testing programme Page summary: A new research project has been announced to evaluate an expansion of the hugely successful HIV opt-out testing programme to new sites across England. Change made: Added a list of hospitals covered by the extension of the HIV opt-out…
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December 8, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter Archive

European Commission study on availability of medical devices on the EU market

European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has contracted Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG) to launch a study for manufacturers of medical devices and in-vitro diagnostics and authorized representatives. The aim of the study is to collect information on the transition of devices to medical devices and in-vitro diagnostic medical devices regulations.…
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December 8, 2023
European Commission Updates Regulatory Affairs NewsletterEuropean Commission Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

New EU Reference Labs designated for Class D IVD devices

The European Commission have designated five EU reference laboratories for high-risk in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2023/2713. These labs will enhance conformity assessments and advisory tasks for devices related to critical health areas like hepatitis, retroviruses, bacterial agents and life-threatening respiratory viruses. The labs are expected to start testing IVDs from October 1, 2024, for tasks…
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December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument published in respect of Northern Ireland

The Department of Health and Social Care have laid a new draft statutory instrument before the House of Commons and the House of Lords on 14 November. Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023 (SI 2023) makes provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament. BIVDA have provided…
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December 8, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 Nov)

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle. MHRA fees* Page summary: Fees payable to the MHRA for 2023…
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December 1, 2023
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 Nov)

Please note this is an extract of the original bulletin. Biggest prostate cancer screening trial in decades to start in UK Page summary: The trial will use innovative screening methods like an MRI scan and see hundreds of thousands of men across the country participating Change made: First published. Government response to the review into commercial clinical trials Page summary:…
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December 1, 2023
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