Ben Kemp – Page 242 – BIVDA Newsletter

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

DBT Weekly Update (WC 26 Aug)

Overseas business risk: Honduras Page summary: The overseas business risk report provides information on security and political risks UK businesses may face when operating in Honduras. Change made: The guidance has been reviewed and updated where necessary, Time updated: 1:32pm, 19 August 2024 Overseas business risk for Guatemala Page summary: The overseas business risk report provides information on security and…

Ben KempAugust 27, 2024

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NHS England’s Advice on Achilles Platform

Your company may have recently received an invitation from various NHS Trusts to join the Achilles platform. This initiative is being piloted by Crown Commercial Services (CCS) as a potential tool for capturing supplier Environmental, Social, and Governance (ESG) data. However, the MedTech Forum have identified concerns about significant overlap between Achilles and existing platforms used by the NHS, such…

Ben KempAugust 27, 2024

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EU Proposed Common Specifications update

Please see the proposed update and introduction of new Common Specifications for Class D devices under the EU IVD Regulation. Please let us know if you have any feedback on the proposals. Note that the consultation close 16th September, so BIVDA will require feedback by Close of Business 13th September. Remember that these will apply in Northern Ireland, and MHRA…

Ben KempAugust 27, 2024

Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

ECHA weekly substance consultations – deadline 30 August

Please provide feedback on the consultations below, if they affect you, so we can pass this information on to MedTech Europe. Please let us know by 30 August. Harmonised classification and labelling consultations: 4-hydroxy-4-methylpentan-2-one; diacetone alcohol (EC 204-626-7, CAS 123-42-2); and 8-methyldecan-2-yl propionate; 8-methyldecan-2-yl propanoate (EC -, CAS 81931-28-4). Proposal to harmonise classification and labelling: reaction products of ammonium bromide…

Ben KempAugust 27, 2024

Environmental Newsletter Environmental Newsletter Archive UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

Resources and Waste Newsletter (from 23 Aug)

Resources & Waste Joint Engagement Forum We held a joint Resources and Waste Forum on Monday 19 August. Read more... Extended Producer Responsibility - Illustrative Base Fees The four UK administrations have published the first in a series of illustrative base fees. Read more... Extended Producer Responsibility - data reporting reminder Obligated producers must report their January to June…

Ben KempAugust 27, 2024

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FDA eSTAR template for MD De Novo Submissions

The FDA have published their Guidance regarding the eSTAR template for Medical Device De Novo Submissions.

Ben KempAugust 27, 2024

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2024 Global Outlook for chemicals & chemical products: Mid-year review for the Americas

During this one-hour webinar, expert analysts will share insights on recently amended regulatory developments across the Americas in 2024 so far, plus look at what’s coming up. Join on Wednesday 4 September by clicking here.

Ben KempAugust 27, 2024

Environmental Newsletter Environmental Newsletter Archive MedTech Europe Updates Environmental Newsletter MedTech Europe Updates Environmental Newsletter Archive

MedTech Europe Response to the Public Consultation on the EU POPs Regulation Implementation of UV-328

MedTech Europe have submitted the attached information, to the EU consultation (Persistent organic pollutants - UV-328 (europa.eu)) on inclusion of UV-328 under the Stockholm Convention on Persistent Organic Pollutants. UV-328 is a UV blocker commonly used to prevent degradation of materials such as plastics. The UK is also a signatory to the Convention, So I’m sharing the MedTech Europe response…

Ben KempAugust 27, 2024

Environmental Newsletter Environmental Newsletter Archive UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

GB MCL Agency Opinions and Technical Reports

A GB MCL Agency Opinion formally proposes the GB mandatory classification and labelling for chemical substances, based on the scientific and technical assessment of the scientific data in line with the GB CLP Regulation, together with an assessment of the policy and socio-economic impacts on the UK. It sets out whether there is adequate scientific evidence to support a new…

Ben KempAugust 27, 2024

Environmental Newsletter Environmental Newsletter Archive UK Government Updates Environmental Newsletter UK Government Updates Environmental Newsletter Archive

Biocides: EU active substance expiry dates and open invitation deadlines

Reminder – upcoming EU active substance open invitation deadlines Submit a notification by the deadline to keep active substances in the EU Review Programme The European Chemicals Agency (ECHA) has published open invitations to provide an opportunity for a person, company or task force/consortium to notify an intention to take up or take over the role of participant in the…

Ben KempAugust 27, 2024