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MHRA publishes draft policy statement on International recognition of medical devices

The MHRA have published a statement of policy intent for recognition of approvals of medical devices from international regulators by the UK. This statement of policy intent is intended to inform partners of the MHRA’s direction of travel. The legislation will come into being at the same time as the future core regulations – anticipated to be late in 2024…

adminMay 22, 2024

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MHRA launches public consultation on common specifications for high-risk IVDs

The MHRA have launched a 4-week public consultation on common specification requirements for high risk IVDs. They are seeking views on the inclusion of these requirements for certain high-risk IVDs and on the removal of the Coronavirus Test Device Approval (CTDA) process from UK MDR 2002. The common specification policy intends to improve the safety profile of high-risk IVDs and…

adminMay 22, 2024

UK Government Updates Regulatory Affairs Newsletter UK 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…

adminMay 22, 2024

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Ukraine introduces CLP regulation

On May 10, 2024, the Ukrainian government approved the Technical Regulation on the classification, labeling, and packaging of chemical products (“UA-CLP”). This regulation integrates the norms of the European CLP Regulation. This regulation will enter into force after 6 months from the date of publication. The text of the regulation, including Annex VIII “Correspondence Table between EU CLP and UA-CLP”…

adminMay 22, 2024

European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive European Commission Updates Regulatory Affairs Newsletter European Commission Updates Regulatory Affairs Newsletter Archive

REACH Restriction of D4/5/6 published in EU Official Journal

The REACH Restriction of D4/5/6 was published in the EU Official Journal on 17 May 2024. It will enter into force 20 days from the date of publication. This marks the end of the legislative process for the regulation of this substance under the Restriction route. The following derogations requested by MedTech Europe have been granted: The new transitional period…

adminMay 22, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive UK Government Updates Regulatory Affairs Newsletter UK Government Updates Regulatory Affairs Newsletter Archive

Office for Life Sciences – publications (WC 13 May)

The Office for Life Sciences have published their latest updates. OLS Stakeholder Bulletin - 17 May Cabinet Office Borders Bulletin - 17 May These include updates on news, including regulatory updates, transitional guidance and events.

adminMay 22, 2024

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

DSIT weekly update (WC 13 May)

Please note this is an extract of the original bulletin. New Zealand: UK Science and Innovation Network summary Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in New Zealand including UK SIN priorities and successes Change made: First published. Call for views on the Code of Practice for Software Vendors Page summary: The…

adminMay 22, 2024

UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

DESNZ weekly update (WC 13 May)

Please note this is an extract of the original bulletin. Managing radioactive substances and nuclear decommissioning Page summary: We’re seeking views on policy proposals for managing radioactive substances and nuclear decommissioning. Change made: Government response and policy framework published. Updated approach to managing nuclear waste Page summary: Updated approach to managing nuclear waste for quicker, safe decommissioning. Change made: First…

adminMay 22, 2024

DEFRA weekly update (WC 13 May)

Please note this is an extract of the original bulletin. Packaging data: how to create your file for extended producer responsibility Page summary: How to structure your packaging data submission. It includes information about the different types of data you need to submit and the codes you need to use. Change made: Updated description of PF code (packed or filled…

adminMay 22, 2024

APHA weekly update (WC 13 May)

Please note this is an extract of the original bulletin. Animals, animal products and HRFNAO imports: authorised border control posts in the UK Page summary: Find an approved UK border control post (BCP) to check the animals, animal products or high-risk food and feed of non-animal origin (HRFNAO) in your consignment. Change made: Fixed the address format for Grangemouth Container…

adminMay 22, 2024