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Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

Strategic Technology Roadmap for the UK IVD Industry

CPI launched a report at an OLS-supported event in Westminster, earlier this year. This report was the result of a comprehensive set of interviews, workshops as well as broad horizon-scanning through the lens of papers and patents. The report addresses the lack of ecosystem, infrastructure, and funding for IVD companies to remain in the UK and the need for a…
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September 15, 2023
Industry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter Archive

UL Standards update

UL have revised their UL 4200A- Products Incorporating Button Batteries or Coin Cell Batteries. The scope has been updated to include: 1.1 These requirements cover household type products that incorporate or may use button batteries or coin cell batteries. 1.2 These requirements do not cover products that exclusively use zinc-air battery technologies. 1.2A These requirements do not cover toy products…
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September 8, 2023
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Dynamic list of standards applicable to IVDs, in collaboration with BSI

BIVDA have collaborated with BSI to develop a comprehensive list of relevant standards that relate to various aspects of IVD product development and manufacturing. We have worked jointly with BSI to compile this list of IVD Standards to help BIVDA members identify those standards relevant to IVD products and organisational needs. While the list aims to provide a clear and…
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September 1, 2023
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BIVDA publishes a position paper on Domestic Assurance

This week, BIVDA have published a position paper on domestic assurance routes to place IVD products on the Great Britain market. This paper presents the stance of the IVD industry in relation to domestic assurance and preferred routes to enter the British market. It highlights the considerations and recommendations to create well-structed market routes, with input provided by the BIVDA…
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August 25, 2023
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Team NB publishes a position paper on new MDR transition timelines and Notified Body capacity

Team-NB have published a position paper on the new MDR transition timelines and Notified Body capacity on 10 August. This paper outlines the members' views on the amended timelines with regards to benefits for the European patients and as the continuity in the availability of essential medical devices in the European market.
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August 18, 2023
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Proposal for new ISO Technical specification on sequencing and clinical application to infectious diseases

The BSI CH/212 IVDs group is responsible for standardization in the field of in vitro diagnostics (IVDs). They have put forward a proposal to develop a new technical specification, ISO/PWI TS 8219: Sequencing and clinical application to infectious diseases. The document covers the essential requirements for advanced sequencing procedure for detecting the microbes directly, without the need for microbial culture.…
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August 4, 2023
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New International Standards on Artificial Intelligence

CEN and CENELEC identifies and adopts two international standards on Artificial Intelligence: EN ISO/IEC 22989:2023 - Information technology - Artificial intelligence - Artificial intelligence concepts and terminology (publication date: 2023-06-28) and EN ISO/IEC 23053:2023 - Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML) (publication date: 2023-06-28). These standards describe the terminology for AI and concepts of AI system…
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June 30, 2023
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BSI receives UKAS accreditation for ISO/IEC 27001:2022

BSI has received UKAS accreditation for ISO/IEC 27001:2022. ISO/IEC 27001- Information Security Management (ISMS) assists organizations in effectively managing and protecting their information assets, so that they remain safe. All ISO/IEC 27001:2022 certificates issued by BSI can now be accredited by the United Kingdom Accreditation Service. More information on ISO/IEC 27001:2022 can be found here.
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June 23, 2023
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