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HGC writes to the European Commission
8 July 2009
On the 22 June 2009 the HGC wrote to the Directorate Generale for Enterprise at the European Commission after the HGC found out that the European Commission would welcome feedback on the recasting of the IVDD Directive and genetic tests covered by the Directive.
The HGC reiterated recommendations made in Genes Direct (2003) and More Genes Direct (2007). The HGC believes that the analytical and clinical validity and clinical utility of genetic tests should be subject to independent pre-market review before tests are placed on the market. To achieve this, the current risk classification of genetic tests, as low risk, should be reviewed.
Click here to read the full letter.
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