Ben Kemp – Page 230 – BIVDA Newsletter

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Upcoming RCC Volunteer Opportunities

RAPS are looking for volunteers to join their Regulatory Compliance Certification Program (RCC) IVD Steering Committee. If you are interested, please fill out and submit the form below: https://connect.raps.org/volunteeropportunities/opportunities-list-public/volunteer-opportunity-details?VolunteerOpportunityKey=29c88aa3-0173-4c28-8e39-0190b796f74e&returnurl=https%3A%2F%2Fconnect.raps.org%2Fvolunteeropportunities%2Fopportunities-list-public Please click here for more information and to sign up: Regulatory Compliance Certification (RCC) Item Bank Maintenance Join the RCC-MDR Committee Join the RCC-IVDR Committee

Ben KempSeptember 4, 2024

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

Final MTE Microplastics clarification question

MedTech Europe have submitted to ECHA a request for clarification questions on the EU REACH restriction on synthetic polymer microparticles. Please see attached. Once they have received the answers, these will be shared with members. MTE Chemicals WG will work on labelling and pictogram suggestions, regarding how to identify affected IVD products that contain microplastics. Please send any feedback you…

Ben KempSeptember 4, 2024

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Register for Global Outlook webinars

Register now for these Chemical Watch webinars: 2024 Global Outlook for chemicals & chemical products: Mid-year review for the Americas Wednesday 4 September - 10:00 EDT / 16:00 CET 2024 Global Outlook for chemicals & chemical products: Mid-year review for Europe, Middle East and Africa Thursday 12 September - 08:00 EDT / 13:00 BST / 14:00 CET 2024…

Ben KempSeptember 4, 2024

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Register now for Rollout of EU Reference Laboratories for IVDR Class D devices – 26 September 2024

Join us for our Rollout of EURLs webinar on 26 September 2024 Hear our subject matter experts Alex Laan, Head of Notified Body – IVD, Sara Fabi, Regulatory Lead – IVD as they discuss the newly enrolled EURL regulation. Class D devices manufacturers will gain more insights in the newly enrolled EURL regulation and will be better prepared for the…

Ben KempSeptember 4, 2024

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New snapshot content: OSHA’s Hazard Communication Standard

Recently, the US Occupational Safety and Health Administration (OSHA) finalized changes to its Hazard Communication Standard (HCS), significantly updating the US standard for classifying, labelling and communicating chemical hazards for the first time in more than ten years. We’re pleased to share a helpful news snapshot, created by the Enhesa Product Intelligence team, that can help you stay informed about…

Ben KempSeptember 4, 2024

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Biocides: Planned removal of entries from GB Article 95 list

Suppliers that have failed to submit the relevant information to HSE will be removed from the GB Article 95 list on 3 March 2025 To remain on the GB Article 95 list there has been a requirement for the supplier to provide relevant information to HSE, including: confirmation of being established in the UK (GB & NI) resubmission of data…

Ben KempSeptember 4, 2024

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Australia Senate Passes New Mandatory Climate Disclosure Law

A bill introducing mandatory climate reporting for large and medium-sized companies passed the Australian Senate, marking a major step towards the establishment of a new climate risk disclosure framework in the country. You can read more here.

Ben KempSeptember 4, 2024

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

Revised F-Gases label format adopted

Dear members, please see below message from MedTech Europe regarding the EU F Gas Regulation, and publication of the labelling implementation legislation. Dear members, With this e-mail, we would like to inform you that the Commission draft delegated act on the updated format for F-gases labels has been adopted on 2 September. The act is available at the link here.…

Ben KempSeptember 4, 2024

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The Misuse of Drugs Act 1971 (Amendment) Order 2024

Draft legislation has been raised for the The Misuse of Drugs Act 1971 (Amendment) Order 2024 (legislation.gov.uk) This maybe of interest to members who provide Drugs of Abuse testing assays, calibrators and controls.

Ben KempSeptember 4, 2024

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Biocides: EU active substance approval dates and open invitation deadlines

Upcoming EU active substance approval dates Apply for product authorisation by the deadlines to keep your products on the NI market The following EU Biocidal Products Regulation (EU BPR) active substance approval dates are coming up: Formic acid (CAS 64-18-6 EC 200-579-1) in product types 2, 3, 4 and 5 1 November 2024 Reaction mass of N,N-didecyl-N-(2-hydroxyethyl)-N-methylammonium propionate and N,N-didecyl-N-(2-(2-hydroxyethoxy)ethyl)-N-methylammonium…

Ben KempSeptember 4, 2024