** UPDATE: the European Parliament will first vote on the text in Committee on 21 March 2017, the text should then be voted upon in Plenary Session on 4 April 2017 **
On 7 March 2017, the Council of the European Union released its position with a view to the adoption of a Regulation on Medical Devices. The Council, the European Parliament and the Commission had reached an agreement in June 2016.
The European Parliament will vote on this text during the upcoming plenary session in Strasburg; the vote has provisionally been scheduled on 21 March 2017.
The provisions pertaining to nanomaterials in this document are similar to the agreement text of June 2016, the classification rules targets nanomaterials as follows :
All devices incorporating or consisting of nanomaterial are:
- in class III if they present a high or medium potential for internal exposure;
- in class IIb if they present a low potential for internal exposure; and
- in class IIa if they present a negligible potential for internal exposure.
The General Safety and Performance Requirements described in Annex I of the regulation have been renumbered, these require in section II.10.6 that:
10.6. Devices shall be designed and manufactured in such a way as to reduce as far as possible the risks linked to the size and the properties of particles which are or can be released into the patient’s or user’s body, unless they come into contact with the intact skin only. Special attention shall be given to nanomaterials.
Please follow this link for the 2014 NIA Briefing on the Medical Devices Regulation and this link to download the position with a view to the adoption of a Regulation on Medical Devices.