The term ‘medical device’ covers a vast range of products from scalpels and sticking plasters to spinal implants and heart valves and a wide variety of drug delivery devices such as prefilled syringes, auto-injectors, inhalers, and infusion pumps. With our material, device and regulatory expertise, Smithers provides advice, support and necessary testing for your ISO 10993 submission.
Support for your medical device submission
The BS ISO 10993 series of standards ‘Biological evaluation of medical devices’ provide methods to assess/show biological compatibility and to characterize materials with particular reference to degradation products and their toxicity assessment.
With world-class chemical analysis facilities and extensive experience, Smithers can undertake testing according to Parts 13 & 18 of ISO 10993
- ISO 10993 Part 13: Identification and quantification of degradation products from polymeric medical devices;
- ISO 10993 Part 18: Chemical characterization of materials.
Other assessments for compatibility with medicinal products and to identify toxicity risks from substances leaking and, using the World Health Organization's terminology, leaching from a medical device can be achieved by performing extractable and leachable studies.
We will devise the methodology and program of work for your product
From more straightforward studies to highly complex scenarios, we can develop a program of work to suit the needs of your product and the relevant submission requirements including:
- Extractables studies to identify any potentially migrating substances.
- Lechables studies to define what migrates and how. Typically required for an implantable device, e.g. a contact lens and often complex to define and conduct.
- Accompanying simulated exposure experiment to assess the levels of those target substances that the patient might be exposed to
Usually comprising both a medical device and an active pharmaceutical ingredient, combination products can be complex from a regulatory point of view, with the FDA, the EMA and MHRA each taking different approaches and responsibilities. For a combination product in the EU, both the MDD and the medicines directive may apply. We will work with you to define the necessary testing and submission requirements.
Please reach out to our experts to discuss your project and explore necessary regulatory requirements.