Regulation of in vitro diagnostic (IVD) medical devices is essential. We are concerned however, that the proposed European Union (EU) Regulation 2012/0267(COD) could restrict access to genetic testing technologies and restrict wider uptake – having an adverse effect on health. Genetic testing is increasingly a standard part of clinical practice in mainstream healthcare, being a useful tool in diagnosis, treatment, predictive testing and management of health conditions.
The regulation will now go through negotiations, and Genetic Alliance UK, along with other patient groups, academics and research organisations, is urging the European Parliament, Council and Commission to support genetic testing technologies. We hope they will find a position that does not restrict access, that is flexible enough to suit the different healthcare systems across the EU, and that has the appropriate scope for this regulation.