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BIVDA updates Regulatory Affairs Newsletter

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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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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…
Tehelj
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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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…
Tehelj
May 19, 2023
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TOPRA training discount for BIVDA members

TOPRA, The Organisation for Professionals in Regulatory Affairs, host a variety of training in the regulatory space that may be beneficial to BIVDA members. To encourage continued development of regulatory knowledge, we are partnering with TOPRA to offer a discount for BIVDA member organisations. A number of courses are planned this year, with a number involving BIVDA engagement: Regulation of…
Ashleigh
April 6, 2023
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