Lord Alton of Liverpool
Crossbench
To ask Her Majesty’s Government, further to the Written Answer by Earl Howe on 10 February (HL4441), what sanctions were imposed by the Human Fertilisation and Embryology Authority on each of the clinics that had administered reagents to permitted gametes or permitted embryos that are then introduced into patients when the reagents concerned had not been CE marked; and how promptly the Medicines and Healthcare products Regulatory Agency was notified of all such instances as documented in inspection reports.
Earl Howe
The Parliamentary Under-Secretary of State for Health
The Human Fertilisation and Embryology Authority has advised that it has not been necessary to impose any regulatory sanctions in relation to the use of non CE marked reagents or products, as the clinics in question have given a commitment, as part of the inspection process, to use alternative CE marked products.
The Medicines and Healthcare products Regulatory Agency was notified that manufacturers were making non CE marked reagents available on 4 December 2013 and 23 November 2014.
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Annotations
Julian Hitchcock
Posted on 9 Mar 2015 11:13 am (Report this annotation)
There is no legal requirement for reagents used for in-house purposes to be CE marked. The requirement applies only where a medical device is placed on the market. It is regrettable that the HFEA, with no obvious authority, makes it a licence requirement that equipment and reagents used in the course of IVF/ART should be CE marked. This is less a guarantee of quality, than that the reagents may be marketed. In passing, it should also be mentioned that medical devices law is concerned with patients. In the IVF context, there is no patient; nor any legal person. European Commission guidance (which is of persuasive significance) provides an extremely strained interpretation of the law, in which the patient is construed as the woman into whose womb the reproductive product will be placed. On this basis, media can be classified as a device, even if the risks to the mother are fanciful. When there is no intention to place such media on the market, but merely to use it clinically in accordance with best clinical practice, the HFEA's well-meant CE-marking requirement serves as an unjustified impediment to treatment quality. I would therefore urge the HFEA to reconsider its position.