BIVDA and the MHRA are holding a joint workshop to socialise aspects of the roadmap, map out the different kinds of support available to developers and understand the pre-market support that industry would like to see from the MHRA.
The MHRA is keen to explore with industry and the IVD UK network, including DHSC, NICE, NHS England, UKRI, the NIHR MICs and the Devolved Administrations where it should position itself in the IVD landscape.
The event is targeted at SMEs as well as multi-nationals, and organisations involved in the development, evaluation and delivery of IVDs. The aim is to further encourage a co-ordinated approach to pre-market support and understand the needs of different stakeholders from a regulatory perspective.
Putting patient safety and well-being first, the MHRA is wanting to take a proactive approach to supporting innovators and continue to build its reputation as a responsive sovereign regulator.
Stakeholders involved will be expected to provide insight based on their experiences; the intention is for this workshop to be engaging and full of discussion.
To understand the level of interest for this event and ensure industry has an opportunity to put themselves forward to be involved, BIVDA has created an Expression of Interest form for member companies to volunteer to take part in the event.
The deadline for completing this expression of interest form is end of the day Friday 13 January.
Please note that submission of this form does not guarantee an invitation to the event. The complete list of companies interested will be passed to MHRA to finalise the invitee list. It is possible that we will not be able to accommodate all companies who are interested.
Only one submission will be accepted from each organisation; where multiple submissions are received, the first response will be taken into account.
If you have any questions, please contact Ashleigh.