To ask Her Majesty’s Government, with reference to paragraph 2.3 of the minutes of 9 March 2017 of the Licence Committee of the Human Fertilisation and Embryology Authority, which non-CE marked reagents will be used by Centre 0017 for the purposes of treatment involving pronuclear transfer between embryos to prevent transmission of serious mitochondrial disease; which laboratories will test the non-CE marked reagents for sterility and toxicity; and why non-CE marked reagents are being used.
The Human Fertilisation and Embryology Authority has advised that it is a condition of a licence that CE marked medical devices must be used wherever possible. In the case of pronuclear transfer, there are no appropriate CE marked reagents, meaning that for treatment to take place, non-CE marked reagents must be used. In this case, the centre must adhere to paragraph 26.5 in Guidance Note 26 of the Authority’s code of practice, which states that if a centre modifies a CE marked product or uses a product “off label”, it must complete a risk assessment and validation to ensure the product is safe. A copy of the Guidance Note 26 is attached.