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Changes to medical device essential principles for nanomaterials

23 Sep 2023

This obligation already existed. Additional detail has been included to help clarify it without introducing new or additional obligations.

7.7 Minimisation of risks associated with nanomaterials
1. A medical device must be designed and produced in a way that ensures that any risks associated with the size and the properties of particles which are, or can be, released into a patient’s or user’s body are minimised.
2. In minimising risks, particular attention must be given to the use of nanomaterials.
3. Subclause(1) does not apply to particles that come into contact with intact skin only
The EU definition of nanomaterials in the Dictionary -
nanomaterial has the meaning given by Article 2(18) of Regulation 2017/745 (as in force from time to time) of the European Parliament and the Council of the European Union