As the IVD industry's representative, BIVDA is committed to ensuring the highest standards of safety and quality of in vitro diagnostics in the interests of patients.
Commercial IVDs used by the NHS, are currently regulated by an EU Directive, which is in UK law under the Consumer Protection Act and which requires continuous vigilance and reporting of product issues to the MHRA by the manufacturer. Additionally, all self-certified CE marked products must have sufficient technical/evaluation data on file and available for independent scrutiny.
BIVDA strongly believes this system is fit for purpose. However, alongside the European organisation, EDMA, BIVDA is an active participant in the current updating of the regulations in the EU. BIVDA is also is fully committed to working with the Department of Health on the Pathology Quality Assurance Review, announced in December 2012. We will continue to lead the in vitro diagnostic industry in the UK on regulatory and quality issues.