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BIVDA updates Regulatory Affairs Newsletter

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2025 BIVDA Regulatory Affairs Seminar agenda released

The agenda for BIVDA’s 2025 Regulatory Affairs Seminar in Birmingham on February 11 - 12 2025 has now been released. Expert figures in diagnostics regulation including David Lawson, Director of Medical Technology, Department of Health and Social Care; Robyn Meurant, Principal Consultant, ACT-IVD; and Megha Deviprasad Iyer, Director of Global Strategic Regulatory Affairs, Thermo Fisher, will lead sessions designed to…
Ben Kemp
December 9, 2024
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUpcoming Events Regulatory Affairs NewsletterUpcoming Events Regulatory Affairs Newsletter Archive

Successful Regulatory Strategy: Best Practices for the Diagnostic Sector

Our 2025 Regulatory Affairs Seminar is bringing together expert speakers to show how to develop a successful regulatory strategy; from bringing products to the market to navigating post-market surveillance. With confirmed speakers from BSI, MedTech Europe, TUV Sud, and the MHRA, the two-day event on 11th and 12th February 2025 is one not to be missed by regulatory specialists. BIVDA's…
Ben Kemp
November 13, 2024
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

2025 Regulatory Affairs Seminar

The Regulatory Affairs Seminar will be held on the 11th and 12 February 2025. BIVDA’s Regulatory Affairs Seminar brings together the UK’s leading regulatory specialists to learn and collaborate.  Next year’s event is being held at the Grand Hotel, Birmingham. Tickets are available at £895 per ticket, the event is currently NOT on Eventbrite so please signal your interest by…
Ben Kemp
September 17, 2024
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

MHRA Fees Consultation Response

The MHRA recently announced a consultation on their statutory fees, running until 24th October. BIVDA have significant concerns about the suggestion of charging per GMDN code. As drafted, this could see fees increasing dramatically - from low hundreds of pounds to tens of thousands annually. The current regulatory transition may also see duplicate charging, where the same device is currently…
Ben Kemp
September 10, 2024
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

WHO consults on collaborative registration procedures guideline

The World Health Organization (WHO) has released a draft version of its updated guideline on practices for national regulatory authorities’ (NRAs) implementation of collaborative registration procedures (CRP) to facilitate the marketing authorization of new medical products within their jurisdictions for products that have either been WHO-prequalified or approved by a stringent regulatory authority. Read more here.
Ben Kemp
August 14, 2024
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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…
admin
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…
admin
August 25, 2023
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BIVDA and MHRA bilateral meeting held on 18 July

On 18 July, BIVDA and MHRA met for our latest one-on-one meeting. The aim of these meetings is to ensure our relationship remains strong and we are able to collaborate on projects key to the IVD sector. The discussions are in addition to our usual day-to-day work with MHRA, specifically involving MHRA’s senior and executive staff. MHRA recently published their…
Ben Kemp
July 21, 2023
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