The European Commission (EC) has revised two regulations under its medical devices directive. One of the amendments states that, 'where applicable, an indication that the device incorporates or consists of nanomaterial' should be shown on the product's label. Furthermore all such devices are categorised as class III chemicals, so as to indicate a high level of concern.
These labeling and classification requirements will apply at all times, 'unless the nanomaterial is encapsulated or bound in such a manner that it cannot be released into the patient's or user's body when the device is used within its intended purpose'. The EC has also stated that 'it is necessary to introduce a uniform definition for nanomaterials based on [the] Commission Recommendation...on the definition of nanomaterial'. This, it states, is necessary 'in order to ensure a high level of health protection, free movement of goods and legal certainty for manufacturers'.
According to the official press release announcing the changes, 'the new rules aim to ensure that patients, consumers and healthcare professionals can reap the benefits of safe, effective and innovative medical devices'.
Follow this link to read the amended medical devices directive, and this link to read the EC's press release announcing the revisions.