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MHRA consultation on Medical Devices Regulations for routes to market and IVDs

The MHRA last week opened their consultation on Medical Devices Regulations for routes to market and in vitro diagnostic devices. This relates to the proposed pre-market Statutory Instrument which is planned to be laid before parliament next year. The MHRA are seeking views as a number of changes have occurred since they previously consulted last year. Areas are: -     International…
Ben Kemp
November 19, 2024
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CLSI C34 | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis

Newly Released Screening & Collection Guidance   CLSI C34 | Sweat Testing: Specimen Collection and Quantitative Chloride Analysis Date of Publication: 8 November 2024 Price: $180 for PDF CLSI C34 describes methods for all aspects of sweat testing, including collection and analysis, results evaluation and reporting, and quality control. You can purchase it here.
Ben Kemp
November 14, 2024
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Latest Blog: Creating a Circular Eco-System for Medical Devices: Single-Use vs Reuse

This is the latest blog in the Creating a Circular Eco-System for Medical Device series that aims to highlight different aspects and challenges of a circular economy in the healthcare and medical device industries. It addresses the principle of reuse and the struggle with choosing single-use or reusable devices, focusing on four (of many) areas that a manufacturer must consider.…
Ben Kemp
November 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Office for Product Safety and Standards Update (WC 11 Nov)

Smarter regulation: UK product safety review Page summary: We’re inviting views on the long-term approach to product safety, and how to ensure that the regulatory framework is fit for the future. Change made: Government response published. Time updated: 9:55am, 5 November 2024
Ben Kemp
November 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Brexit Update (WC 11 Nov)

Trade and Cooperation Agreement Partnership Council Decision number 1 for 2024: updates to product specific rules Page summary: Information on the Partnership Council’s first decision in 2024 on updates to a number of Product Specific Rules in the Rules of Origin annexes of the TCA. Change made: First published. Time updated: 11:00am, 6 November 2024 Trade and Cooperation Agreement Governance…
Ben Kemp
November 14, 2024
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

DBT Update (WC 11 November)

Labour Market Enforcement Strategy 2025 to 2026: call for evidence Page summary: Call for evidence from Margaret Beels, the Director of Labour Market Enforcement, to inform her labour market enforcement strategy for 2025 to 2026. Change made: First published. Time updated: 9:00am, 4 November 2024 Making Work Pay: creating a modern framework for industrial relations Page summary: We are consulting…
Ben Kemp
November 14, 2024
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Share your views on UKRI: participate in the stakeholder survey

UKRI are seeking feedback on perceptions of the organisation. The survey should take no more than 15 minutes to complete, and your responses will help UKRI to address issues, tailor their activities and measure their progress as an organisation over the coming years. Take the survey here.
Ben Kemp
November 14, 2024
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Assess Your Organisation’s Cybersecurity Maturity

You are invited to participate in MDIC’s Medical Device Cybersecurity Maturity Industry Benchmarking Assessment designed to help medical device manufacturers further examine their cybersecurity posture and address potential risks across the total product life cycle. Your participation provides critical insights into the current state of cybersecurity maturity in the medical device industry. By participating, your organization will receive a confidential…
Ben Kemp
November 14, 2024
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