EU bodies negotiate new EU Medical Devices Regulations

The European Union are currently negotiating two new draft Regulations that aim to ensure medical devices are safe and have high quality. Discussions were underway between the European Parliament and the European Commission on a Medical Devices Regulation and In-Vitro Medical Devices Regulation. It has been proposed by the European Council that well-being mobile apps are not caught by the new Regulations; this contrasts with software which is intended to be used for one or more medical purposes, which would fall within the remit of the new laws.

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Published on 21. October 2015 in News EU