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.
This last version of the Regulation contains rephrased specific provisions for the use of nanomaterials in medical devices. These were originally outlined in the proposal by the European Commission and the version amended by the European Parliament.
Classification rules set out in Annex VII outline the system to be followed, in its new version the text reads:
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;
- in class IIa if they present a negligible potential for internal exposure.
In addition, the General Safety and Performance Requirements described in Annex I of the regulation require, in section II.7.6 that:
7.6. 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 full tentatively agreed consolidated compromise text of the Regulation.