Ben Kemp – Page 180 – BIVDA Newsletter

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Resources and Waste Newsletter – Friday 13 December 2024

You can find the newsletter here. Please see comments in bold below explaining how different sections impact members: Circular Economy Reflections & Outlook: Impacts how companies design products for reuse, remanufacturing, or recycling, and the use of materials collected and made available through recycling, etc. Simpler Recycling in England: This impacts how companies collect and sort waste for recycling…

Ben KempDecember 18, 2024

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General product safety regulations: Great Britain

Following the update of the EU General Product Safety Regulation, which applies as product related legislation in Northern Ireland. Note that this will have a direct impact on Research use only, general health and wellbeing products and Veterinary Use products placed on the Northern Ireland market, sold to consumers i.e. not sold business to business for professional use. However, the…

Ben KempDecember 18, 2024

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Biocides: GB active substance dossier submission deadlines and expiry dates

Upcoming GB active substance dossier submission deadlines Take action to keep your active substance in the GB Review Programme The active substance/product type combinations listed have been successfully notified into the GB Review Programme following open invitations. The next step is for a full active substance dossier to be submitted to HSE by the following deadlines: 21 March 2025 (Benzylyoxy)methanol…

Ben KempDecember 18, 2024

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MHRA Strategy for Improving Safety Communications

The MHRA launched the new MHRA Strategy for Improving Safety Communications - GOV.UK (www.gov.uk) in September, through which they aim to transform the way they communicate about the risks and safety of medicinal products in the UK and to embed action on new safety issues at the heart of health and care practice. The strategy includes wholesale change to the…

Ben KempDecember 18, 2024

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TGA – Australia ARTG page update

TGA Australia have update the ARTG webpage - Australian Regulatory Guidelines for Medical Devices (ARGMD) | Therapeutic Goods Administration (TGA)

Ben KempDecember 18, 2024

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MHRA: Laura Squire’s final blog of the year

Dear members, Laura Squire, MHRA, has issued her latest blog taking a step back to review the last 12 months, and to publish an updated roadmap looking into activities planned for 2025. Festive reflections on Med Tech – MedRegs

Ben KempDecember 18, 2024

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Electromagnetic Compatibility Regulations 2016

Electromagnetic Compatibility Regulations 2016 Page summary: Guidance for businesses. Change made: Guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into effect on 1 October 2024. Time updated: 11:29am, 11 December 2024

Ben KempDecember 18, 2024

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

Electrical Equipment (Safety) Regulations 2016

Electrical Equipment (Safety) Regulations 2016 Page summary: Guidance for businesses. Change made: Guides revised following legislation to extend recognition of CE marking on products being placed on the Great Britain market which came into effect on 1 October 2024. Time updated: 11:29am, 11 December 2024

Ben KempDecember 18, 2024

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EU RoHS update

Dear members, Please see below update we have received from MedTech Europe regarding the proposed inclusion of TBBP-A and MCCP in the scope of EU RoHS. I hope you are all well. We would like to share an update with you regarding the status of the inclusion of TBBP-A and MCCP in RoHS. A few years ago, as part of…

Ben KempDecember 18, 2024

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ECHA Weekly: Revised rules for classification, labelling and packaging enter into force

Revised rules for classification, labelling and packaging enter into force The updated Classification, Labelling and Packaging (CLP) Regulation started to apply on 10 December 2024. We encourage companies to review their substance portfolios and update classifications as needed. The updated CLP Regulation aims to better identify and classify hazardous chemicals, as well as improve the communication on chemical hazards.

Ben KempDecember 18, 2024