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BSI webinar on the impact of the EU AI Act

BSI are hosting a webinar about updates on the EU AI Act progress, covering its history, the significant elements of the recent December deal, and its potential impact on various industries on 27 February. The webinar will include an explanation on EU AI Act and strategies to prepare for the Act's implementation. Members who are interested in attending this webinar…
Tehelj
February 14, 2024
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Upcoming webinars

ISO 37001: How to prepare for the certification process ISO 37001 is an international standard on Anti-bribery management systems that allows organizations of all types to prevent, detect and address bribery. Speeki Pte Ltd are hosting a webinar about the the ISO 37001 certification process on 22 February. The webinar will include practical advice on preparing for a successful ISO…
Tehelj
February 14, 2024
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IP and Business Growth Survey 

Intellectual Property Office are inviting businesses to respond to our survey on IP and business growth. They are asking businesses to share their views on the role intellectual property plays in supporting the growth of their business. The survey is split into the following sections: Section 1 covers information about your business. You will be asked questions on your location,…
Tehelj
January 31, 2024
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BioMedical Alliance publishes a statement on shortage of diagnostic tests

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”. This document points to the persisting problems with the implementation of EU IVDR. It calls…
Tehelj
January 24, 2024
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New available International Standards on Artificial Intelligence

CEN and CENELEC identifies and adopts two international standards on Artificial Intelligence: ISO/IEC/TR 24027:2023 - Information technology - Artificial intelligence (AI) - Bias in AI systems and AI aided decision making and ISO/IEC TR 24029-1:2021 - Artificial Intelligence (AI) - Assessment of the robustness of neural networks - Part 1: Overview. These standards are available from 20 December.
Tehelj
January 3, 2024
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UL Standards update (WC 30 Nov)

UL have published the following documents between 30 November and 15 December: Standard UL 2900-1 Ed. 2 Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements CSDS Proposal UL 62133-2 Ed. 1 Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, and for Batteries Made from Them, for Use in Portable…
Tehelj
December 20, 2023
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ISO 13485 Stakeholder Feedback Survey

In follow up to the plenary discussions in December 2022, ISO/TC 210 (AAMI QM, Quality management and corresponding general aspects for products with a health purpose including medical devices) Working Group has begun preparatory work on items for future revision of ISO 13485:2016. The technical committee have launched a survey seeking feedback on the use of the standard for regulatory…
Tehelj
December 20, 2023
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New EU Reference Labs designated for Class D IVD devices

The European Commission have designated five EU reference laboratories for high-risk in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2023/2713. These labs will enhance conformity assessments and advisory tasks for devices related to critical health areas like hepatitis, retroviruses, bacterial agents and life-threatening respiratory viruses. The labs are expected to start testing IVDs from October 1, 2024, for tasks…
Tehelj
December 8, 2023
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MedTech Europe RAC

This week, BIVDA was represented at MedTech Europe Regulatory Affairs Committee (RAC) by Stuart and Tehelj. The meeting was also attended by members of the European Commission. It was a constructive meeting with a focus on the published paper on the Future of Europe's Medical Technology Regulation, and the continued challenges on the transition to the EU IVD Regulation.
Stuart Angell
November 24, 2023
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BSI webinar on EU IVDR regulatory updates

BSI are hosting a webinar about the latest IVDR regulatory updates on 28 November. The webinar will include a short recap on where the IVDR is, along with latest MDCG guidance and developments in Brussels; description of the challenges for Class D IVD’s and the status on EU Reference Labs and envision the potential ramifications for manufacturers of these updates.…
Tehelj
November 24, 2023