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IMDRF publishes “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)”

On 25 June, the IMDRF published their updated "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." This document sets out significant revisions based on regional policy changes since the last update was published in 2019. The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical…
Tehelj
June 25, 2024
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Cystic Fibrosis Trust Industry Symposium

The Cystic Fibrosis Trust are hosting an industry symposium "Accelerating CF Research: Strategies for rapidly progressing your science to clinical impact" on the 05 June 2024 in Glasgow. This event aims to showcase the support available for researchers to tap into and ways to accelerate their research projects. More information on this event and registration can be found here.
Tehelj
May 22, 2024
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BSI webinar on achieving net zero goals

BSI are hosting a free webinar on how a small business can achieve net zero goals on 11 June. The webinar will include include an introduction to BSI Flex 3030 and what it aims to do, user community discussion on BSI Flex 3030, how best it can be applied, and its impact, a Q&A session and audience feedback and introduction…
Tehelj
May 8, 2024
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IMDRF publishes a new guidance document

The IMDRF have published a new guidance document "Principles of Labeling for Medical Devices and IVD Medical Devices" (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)). This document provides a globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). This document…
Tehelj
May 1, 2024
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Qserve free webinar: EU-IVDR two years on!

Qserve are hosting a free webinar on "EU-IVDR two years on!" where Sue Spencer will explain what the proposed extension of the IVDR means for manufacturers and how IVD manufacturers can understand and effectively use the IVDR transition for successful CE marking. This webinar aims manufacturers to help them by sharing the current state of play, what is the extension…
Tehelj
April 24, 2024
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Call for expertise on the development of IEC 61010-2-101

BSI are looking for experts in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017), to join their committee EPL/66 in developing the above standard which is undergoing a revision. BIVDA members who may be interested in joining this committee are requested to contact Regulatory@bivda.org.uk.
Tehelj
April 17, 2024
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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