Source · Select Committees · Science, Innovation and Technology Committee
Recommendation 15
15
Deferred
Prenatal genomic testing could influence decisions on terminating fetuses, leading to specific concerns in addition...
Recommendation
Prenatal genomic testing could influence decisions on terminating fetuses, leading to specific concerns in addition to the issues concerning other types of direct-to- consumer genomic testing. The Government should consider if any restrictions should be placed on the conditions that prenatal genomic tests provided directly to consumers are able to test for. (Paragraph 99) 54 Direct-to-consumer genomic testing
Government response summary AI-generated
The government states that current MHRA regulations limit action to compliance or safety issues. It will encourage and facilitate future discussions between MHRA and UKNSC regarding policy but does not commit to the government actively considering restrictions itself.
Summary of the government's response below — read the verbatim text to verify.
Government Response
Deferred
HM Government · verbatim extract
Deferred
Under the UK Medical Device Regulations 2002, the MHRA could only take action against the use of certain genomic tests if a compliance or safety issue associated with the device had arisen. The MHRA proactively investigate and review adverse incident reports for all medical devices placed onto the UK market and take necessary regulatory action where needed. The UKNSC is keen to be involved in any future discussions with MHRA to advise on policy relating to recommendation 14. The Government will encourage and facilitate these discussions where appropriate.
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