EU Regulation on in-vitro Diagnostic Medical Devices – call for urgent action !

The European Commission issued a proposal for a new Regulation on in vitro diagnostic devices in September 2012. At the committee stage in the European Parliament, the Rapporteur Peter Liese, MEP introduced an entirely new article into this proposed Regulation. The article is focused on the practice of genetic medicine, and seeks to regulate what happens in clinics and hospitals where patients may have a genetic test as part of their medical care.

In May 2013, the European Society of Human Genetics issued a position statement opposing this new article, stating that the provisions of the article were “unworkable in the daily practice of genetic medicine.”

A version of the Regulation containing this new article was recently passed by the committee, and will be voted on at the European Parliament on October 21. It is very important that this article is removed at the European Parliament vote, or it may become European law.

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