Ben Kemp – Page 243 – BIVDA Newsletter

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Biocides: EU active substance open invitation deadline and active substance expiry dates postponed

The EU deadline to submit a notification to keep substances in the EU review program (Including for Northern Ireland) for Pyrithione zinc (zinc pyrithione) (CAS 236-671-3 EC 13463-41-7) in product types 2 and 10 21 December 2024

Ben KempAugust 14, 2024

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Swissmedic – first modules go live with Swissdamed database

Swissmedic have announced that the first two modules (actor and device) of the Swiss national regulators database 'Swissdamed’ have gone live.

Ben KempAugust 14, 2024

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BSI Webinars – Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits

Sign-up for the 'Understanding and meeting the EU IVDR requirements for In Vitro Diagnostics (IVD) Kits' webinars. You can register for the morning session here and the afternoon session here.

Ben KempAugust 14, 2024

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MDSAP have updated their Audit Approach Guidance

MDSAP (Medical Device Single Audit Program (MDSAP) | FDA) have updated their Audit Approach Guidance. You can read them here.

Ben KempAugust 14, 2024

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UK government to introduce legislation aimed at regulating ESG ratings providers in 2025

The UK government will introduce legislation aimed at regulating ESG ratings providers in 2025, according to a speech Wednesday by Chancellor of the Exchequer Rachel Reeves, and confirmed today in a statement by the finance ministry, HM Treasury. Read more here.

Ben KempAugust 14, 2024

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US SEC goes to court to defend its right to require climate disclosures for US listed companies

The U.S. Securities and Exchange Commission launched a defense in court of its new climate reporting rule, arguing that the proposed disclosures in the rule provide “information directly relevant to the value of investments,” and that it is within the Commission’s authority to mandate climate risk disclosures. You can read more here.

Ben KempAugust 14, 2024

Environmental Newsletter Environmental Newsletter Archive European Commission Updates Environmental Newsletter European Commission Updates Environmental Newsletter Archive

EU Commission publishes sustainability FAQs

The European Commission has published FAQs for the: Corporate Sustainability Reporting Directive Frequently asked questions on the implementation of the EU corporate sustainability reporting rules - European Commission (europa.eu) And Corporate Sustainability Due Diligence Directive 7a3e9980-5fda-4760-8f25-bc5571806033_en (europa.eu)

Ben KempAugust 14, 2024

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CLSI have updated EP30 – Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 2nd Edition

CLSI have updated EP30 – Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 2nd Edition. Updated to align with the current ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples and current versions of CLSI EP14 Evaluation of Commutability of Processed Samples, 4th…

Ben KempAugust 14, 2024

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Scottish Government continues virtual ward drive amid positive report

The Scottish Government is set to continue its efforts to expand the number of patients utilising NHS Scotland’s Hospital at Home service, backed by £3.6 million in new funding. Recent data reveals that nearly 15,000 older patients benefited from the service last year, marking an increase of almost 25% compared to the previous year. Thirteen healthcare providers have been granted…

Ben KempAugust 14, 2024

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EU IVD Regulation 2017/746 updated

EU IVD Regulation 2017/746 consolidated version has been updated with the latest transition timelines and amendments. You can access the legislation here.

Ben KempAugust 14, 2024