European Union

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.

REACH Guidance Moritorium will not Apply to Nano Updates

The European Chemicals Agency (ECHA) issued a clarification yesterday that ongoing REACH guidance documents, several of which address nanomaterials, will not be halted under the upcoming two-year 'moratorium' that was recently announced. Under this moratorium, ECHA was expected to pause any further updates to REACH in order to allow companies time to adjust their practices and come into compliance in advance of the 31 May 2018 registration deadline. However, 15 guidance documents will be excluded from the moratorium, with four concerning nanomaterials: