Skip to main content
BIVDA updates Regulatory Affairs NewsletterBIVDA Updates Regulatory Affairs Newsletter ArchiveIndustry Newsletters Regulatory Affairs NewsletterIndustry Newsletters Regulatory Affairs Newsletter ArchiveMembership NewsMembership News ArchiveRegulatory Affairs NewsletterRegulatory Affairs Newsletter Archive

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
August 25, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Uncategorized

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…
Read More
July 21, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

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…
Read More
May 19, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive

BIVDA’s new Regulatory email

BIVDA has recently established a new email address dedicated to handling all regulatory enquiries. If you have any questions, concerns, or require assistance regarding regulatory matters or any events, we kindly ask you to contact our Regulatory Affairs email (Regulatory@bivda.org.uk). This will then be managed by either Ashleigh or Tehelj. If you are awaiting a response to any questions sent…
Read More