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 UKCA sub-group. The paper also emphasises on the requirement of timely guidance in relation to market routes and the importance of recognizing international markets within domestic assurance.
Alongside publication to the BIVDA membership, the paper is provided to the UK government where we hope the paper will be used to shape the future regulatory requirements in a realistic manner.