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In Vitro Fertilisation

Question for Department of Health

UIN HL5622, tabled on 11 March 2015

To ask Her Majesty’s Government to what extent Council Directive 93/42 EEC of 14 June 1993 concerning medical devices and Directive 98/79 EEC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices applies to items such as IVF laboratory equipment or reagents where there is no intention to place such items on the market; how it is possible for a fertility clinic to obtain CE marking for items that they do not intend to place on the market for the purposes of HFEA licence condition T30; and what consideration is given to the quality, safety and efficacy of in-house products that conform to the highest clinical standards and which demonstrably exceed those of marketed equivalents.

Answered on

24 March 2015

The Human Fertilisation and Embryology Authority (HFEA) has informed us that it has been advised by the Medicines and Healthcare products Regulatory Agency (MHRA) that medical devices manufactured and used within the same healthcare institution without having been transferred to a different legal entity do not come within the scope of the Medical Devices Directives referred to, and do not therefore need to be CE marked.

I have nothing further to add to my previous answer of 20 February 2015, HL4711, regarding HFEA licencing conditions and guidance in relation to the use of CE marked and non-CE marked products.