Source · Select Committees · Science, Innovation and Technology Committee
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
Acknowledged
HM Government
Acknowledged
The outcome of MHRA’s public consultation will help to inform future policy on how DTC genomic tests are regulated and in turn, how they are assessed prior to being placed on the UK market.