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Joint Statement on In Vitro Diagnostic Medical Devices Regulation | 01.06.15

 

EASAC has joined a number of stakeholders and organizations in signing the “Joint Statement on the potential impacts of the proposed In Vitro Diagnostic Medical Devices Regulation 2012/0267(COD) and amendments on genetic testing provision”, which has been initiated by the Wellcome Trust and the PHG Foundation.

The regulatory framework governing medical devices in the European Union is currently being revised in order to account for scientific developments and provide a regulatory framework for in vitro diagnostic medical devices that is fit for purpose. The signatories to the joint statement broadly support the European Commission’s proposals. There are concerns, however, that some of the amendments adopted by the European Parliament to the proposed In Vitro Diagnostic Medical Devices Regulation could have damaging effects on the provision of genetic tests for patient benefit and could potentially limit the uptake of new healthcare innovations.

Link to Joint Statement

Link to Wellcome Trust dedicated website