To ask Her Majesty’s Government what are the criteria employed by the Human Fertilisation and Embryology Authority in determining which equipment, products or reagents require CE marking in order to be used in either research or clinical practice by all licensed centres.
Answered on
20 February 2015
The Human Fertilisation and Embryology Authority (HFEA) licencing conditions state that:
“Wherever possible only CE marked medical devices must be used.”
Further, HFEA guidance states that:
“The centre should use only media and consumables that have been CE-marked at a classification suitable for their intended purpose. Modifying existing devices (for example, adding calcium ionophore to culture medium) or using them ‘off label’ for purposes not intended by the manufacturer (for example, using a medium for a different purpose from that specified) has safety implications. It may also count as
manufacture of a new device under the Medical Devices Regulations.”
“If the centre does choose to modify an existing product or use a product ‘off label’, it should (as the ‘manufacturer’) complete a risk analysis and validation to ensure the product or process is safe.”