Source · Select Committees · Science and Technology Committee (Commons)
Recommendation 3
3
Paragraph: 41
Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their...
Recommendation
Most manufacturers of genomic tests sold directly to consumers can self-certify the conformity of their products to performance requirements. The Medicines and Healthcare products Regulatory Agency has suggested that this restricts its ability to ensure that genomic tests on the UK market provide reliable results. The Government should require manufacturers of direct-to-consumer genomic tests to have the performance of their tests assessed by an external body prior to placing their products on the UK market.
Paragraph Reference:
41
Government Response
A response document is linked to this report, dated 1 November 2021. Response attribution to this recommendation has not been verified. Read the response document ↗