Source · Select Committees · Science, Innovation and Technology Committee
Recommendation 3
3
Deferred
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.
Government response summary AI-generated
The government states that the outcome of MHRA's public consultation will inform future policy on regulating and assessing direct-to-consumer genomic tests, deferring a decision on requiring external assessment.
Summary of the government's response below — read the verbatim text to verify.
Paragraph Reference:
41
Government Response
Deferred
HM Government · verbatim extract
Deferred
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.
Read the full response on Parliament ↗