European Regulators Issue Guidance on Nanotechnology in Medical Devices

The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.

Issued by the Commission’s Scientific Committee on Emerging and Newly Identified Health Risks, the guidance recommends assessments of devices with nanomaterials in conjunction with the ISO 10993-1:2009 standard for biological safety evaluations of medical devices.

ISO 10993 applies to multiple aspects of safety testing and risk assessment of devices, but the standard does not currently address evaluation and assessment of devices incorporating nanotechnologies. (An addition to the standard covering nanomaterials is forthcoming from ISO.)

Until more substantive guidance is added to ISO 10993, European regulators recommend conducing risk assessments of devices with nanomaterials using a case-by-case approach. Evaluations of nanotechnologies should take into account parameters such as chemical composition, particle size and concentration, physical form and surface chemistry, and how they could impact the health of a user or patient exposed to the device.

The guidance recommends the following four-phase evaluation to assess potential risks of devices incorporating nanotechnologies:

• Phase 1 exposure assessment: what is the probability that nanoparticles from the device will be released during the product’s use and removal?
• Phase 2 exposure assessment: what is the likelihood that exposure to a nanomaterial will result in distribution of that nanomaterial to other external or internal parts of a patient or user’s body? How long will that nanoparticle remain in the sites into which it has been distributed?
• Phase 3 hazard assessment: what are the local and/or systemic effects of a nanomaterial that has been distributed to other parts of the patient or user’s body?
• Phase 4 risk characterization and assessment: categorization of a nanomaterial’s risk based on amount and duration of toxicity introduced through its use

Stewart Eisenhart