28 April 2006
HFEA Standards for Assisted Conception Centres
The enclosed Standards for Assisted Conception Centres have been drafted collaboratively by the HFEA and the professional bodies of the assisted conception sector.
On 7th April 2006 the European Tissues and Cells Directive (Directive 2004/23/EC) came into force. These Standards include the technical requirements of the Directive, and set out the measures that centres must address in order to demonstrate compliance when inspections under the Directive start in April 2007.
The Directive requires the implementation of a total quality system and the Standards set out a framework for a quality system applicable to the assisted conception sector. They also incorporate good practice measures relating to each relevant discipline, as recommended by the professional bodies.
Centres must plan their implementation of the Directive against these Standards.
Purpose and use of the Standards
The Standards will be used to underpin the inspection process and assess licence applications under the Directive, including the previously unlicensed IUI and GIFT centres.
The Standards are also a mechanism to:
- Bring together regulatory and professional guidelines covering the entire patient pathway;
- Encourage consistency and a drive for continual improvement
Status of the Standards
The Standards, which contain the requirements of the European Tissues and Cells Directive, will be mandatory from 7 April 2007. By then regulations to transpose the Directive to UK law will be in place.
For now the Standards are being circulated as a working document. The Standards will be finalised by the end of this year and all centres will be provided with the final draft. (In the longer term the European Commission has undertaken to review the technical requirements of the Directive from time to time, but it is not yet clear how often this will be. The Standards will be updated accordingly.)
Work is also underway to produce the 7th edition of the HFEA Code of Practice. The Code and the Standards will be merged to form one standards based document. It is planned that this will be published by April 2007.
Feedback from centres
We welcome initial feedback on any aspect of the Standards between now and May 31st. (Please use the template attached to provide feedback.).
If you have any informal queries about the Standards, other than the feedback invited within the enclosed template, please contact Charles Lister, Head of Policy on 0207 291 8230 (firstname.lastname@example.org) or Jenny Dimond, Policy Manager on 0207 291 8238 (email@example.com).
Page last updated: 24 August 2012