Revised Rule on Nanomaterials in the Trilogue Compromise Text for Medical Devices Regulation

On 15 June 2016, the three institutions of the European Union reached an agreement on the Regulation on Medical Devices. The Council, the European Parliament and the Commission had engaged in a trilogue procedure after the vote of the European Parliament in April 2014.

In the tentatively agreed consolidated compromise text, the institutions of the European Union set rules for more control over the production of medical devices and ‘Notified Bodies’. It also introduces an ‘implant card’ for patients and increased scrutiny on high risk devices.