IVD regulation and the oversight of genetic testing – global trends and stakeholder perspectives


From 27 Oct 2011
Until 28 Oct 2011


By Invitation Only


IVD regulation and the oversight of genetic testing – global trends and stakeholder perspectives
Leuven, Belgium on 27-28 October 2011
Draft programme

Professional and public concern that genetic tests were being introduced into clinical practice with insufficient evidence of their safety and effectiveness has been considered by a series of committees in the US, Europe and elsewhere. Concerns were first articulated as early as 1975 in a report from the National Academy of Sciences entitled Genetic Screening Programmes, Principles and Research. In the years since then there has been a prolonged policy debate about how best to ensure the safe and appropriate use of clinical genetic tests; a number of committees and task forces in the North America, Europe and elsewhere have reviewed the oversight of genetic testing and their reports have come to similar conclusions. There has been a general consensus that genetic tests should not enter routine clinical practice without thorough independent evaluation. However, there has been less agreement about how to implement this policy, and the only country to carry out a comprehensive reform of their regulatory regime is Australia. In the last two years the US FDA and the European Commission have both embarked on public consultation exercises in preparation for addressing some of the current gaps in their regulatory frameworks.


This workshop has been organised by the EuroGentest network to discuss impending reform of IVD device regulation in the USA and the EU and its impact on genetic tests and molecular diagnostics more broadly, with a particular focus on what we believe are three of the most critical issues: risk classification, laboratory-developed tests and consumer genetics. The workshop will bring together senior representatives of the full range of stakeholders including clinicians, scientists, industry, patient/consumer groups and policymakers. The intention is to share information; explore areas of similarity and divergence in plans for reform of IVD regulations; identify potential for harmonisation and those areas where harmonisation unlikely/impossible; explore stakeholder views; explore mechanisms/fora for harmonisation and potential role of EuroGentest and other stakeholders in this process.


Attendance to this meeting is by invitation only; a report of the meeting will be issued in due course.

Documents & Links

IVDWorkshop_Program.pdf377 K
About EuroGentest
About Us
Standards Valid XHTML 1.0 Transitional Valid CSS!
European Union
Contact Information
Center for Human Genetics
University of Leuven
Herestraat 49 Box 602, 3000 Leuven, Belgium
webmastereurogentestorg, Tel: +32 16 340321, More...

Copyright EuroGentest2 Coordination Action 2011 - EU Contract no.: FP7 - HEALTH-F4-2010-261469