Changes to medical device Essential Principles for nanomaterials

Essential Principle 7 now explicitly requires that particular attention must be given to the chemical and physical properties and biocompatibility of materials used in medical devices in relation to nanomaterials.

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

The Therapeutic Goods (Medical Devices) Regulations 2002 now includes:

• 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

Download the new Essential Principles checklist for medical devices.