Standards for Assisted Conception Centres

The HFEA, in collaboration with the professional bodies of the assisted conception sector, have drafted a set of Standards for Assisted Conception Centres. These Standards include the technical requirements of the European Tissues and Cells Directive (Directive 2004/23/EC) which came into force on 7th April 2006. They set out the measures that centres must address in order to demonstrate compliance when inspections under the Directive start in April 2007 and centres must plan their implementation of the Directive against these Standards.

The Directive requires the implementation of a total quality system and the Standards set out a framework for a quality system that can be applied to the assisted conception sector. They also incorporate good practice measures relating to each relevant discipline, as recommended by the professional bodies.

A copy of these Standards has been sent as a working document to all centres with Chief Executive's letter CE (06)01.The Standards will be finalised by the end of this year and all centres will be provided with the final draft. It is planned that the 7th edition of the Code of Practice will be merged with the Standards and published by April 2007.  The Standards will then become mandatory from 7 April 2007.

In the meantime we welcome initial feedback on any aspect of the Standards. Please use the template attached to Chief Executive's letter CE(06)01.

If you have any queries about the Standards please contact:

Charles Lister, Head of Policy on 0207 291 8230 (charles.lister@hfea.gov.uk) or

Helen Coath, Policy Manager on 020 7291 8238 (helen.coath@hfea.gov.uk).

Standards for Assisted Conception Centres
Draft for comment and discussion (199 Kb)

> Read  the evidence and reasoning behind the HFEA's current policy position on the level of air quality required under the EU Tissues and Cells Directive