Question to the Department of Health and Social Care:

To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 20 February (HL4711) and the Written Answer by the Parliamentary Under-Secretary of State for Public Health, Jane Ellison, on 25 February (HC224623), what criteria are used by the Medicines and Healthcare products Regulatory Agency (MHRA) and the Human Fertilisation and Embryology Authority (HFEA) in determining whether the modification of an embryo culture medium by a clinician prior to its use with permitted gametes or embryos and their ensuing introduction into patients would be considered as the manufacture of a new medical device; and whether the MHRA is notified of individual instances as reported in HFEA inspection reports when the users and manufacturers of such products would accordingly be considered as the same individuals.

The Human Fertilisation and Embryology Authority (HFEA) has advised that it does not have criteria for determining whether the modification of an embryo culture medium by a clinician prior to its use with permitted gametes or embryos and their ensuing introduction into patients would be considered as the manufacture of a new medical device. Where the HFEA has been made aware that clinics were being advised by the manufacturer to modify a CE marked culture medium, it has sought advice from the Medicines and Healthcare products Regulatory Agency (MHRA) on whether this constituted manufacture by the clinic.

The HFEA has also advised that the MHRA has not been notified of individual instances of the modification of an embryo culture medium as reported in inspection reports. The MHRA has advised the HFEA that medical devices manufactured for own use, that is not made available for sale to others, do not fall within the remit of medical devices regulations.