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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
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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…
Tehelj
September 1, 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.…
Tehelj
August 4, 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.
Tehelj
June 23, 2023
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Upcoming BSI Webinar: EU AI Act Explained: Navigating the new legislation with BSI

BSI are hosting a Medical Devices webinar on EU AI Act Explained: Navigating the new legislation with BSI. The EU Artificial Intelligence (AI) Act is a proposed European law on artificial intelligence the first law on AI by a major regulator. This webinar will look in detail at the EU AI Act, discussing the framework, the approach, the timeline, and the…
Tehelj
June 8, 2023
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BSI has adopted standard for electrical safety

BSI have adopted IEC 61010-2-101:2018 as a British standard. BS EN IEC 61010-2-101:2022/A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment considers electrical safety requirements for IVD equipment, and should be considered for manufacturers with products in this space.
Ashleigh
May 5, 2023
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Reminder: BSI looking for contributors for safety requirements for electrical equipment for measurement, control and laboratory use standard

A reminder that BSI have put a call out for those interested and knowledgeable 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). This is to join their committee EPL/66, Safety of measuring, control and laboratory equipment’ in developing the above standard which is undergoing a revision.…
Ben Kemp
March 9, 2023
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BS EN 556-2 EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated ”STERILE”. Part 2: requirements for aseptically processed medical devices

This document specifies the requirements for an aseptically processed medical device to be designated 'STERILE'. Please comment by 14 March 2023. To access the full document, click here. NOTE For the purpose of the EU Directive(s) for medical devices (see Bibliography), designating that a medical device is 'STERILE' is permissible when a validated manufacturing and sterilization process has been applied. Requirements…
Ben Kemp
January 27, 2023
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