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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…
Ben Kemp
August 25, 2023
Membership NewsMembership News ArchiveRegulatory Affairs Working PartyRegulatory Affairs Working Party Archive

BIVDA UKCA sub-group

BIVDA previously ran a UKCA sub-group which was an off-shoot of the Regulatory Affairs Working Party. This group hasn’t met recently due to insufficient content. Now that we have slightly more clarity on the UKCA regulations and MHRA have committed to introducing timeline legislation in Spring 2024, we thought this was the opportune time to restart this group. The UKCA…
Ben Kemp
November 3, 2022
Membership NewsMembership News Archive

A Regulatory Recap

EU IVDR The EU IVDR date was application was 26 May 2022, with a number of the key dates now amended to provide more time for compliance in line with the risk class of the device. The new dates for implementation will be: 26 May 2024 for certain requirements for devices manufactured in-house (2028 to demonstrate unavailability of an equivalent…
Ben Kemp
June 1, 2022