The ISO 10993 series of standards ‘Biological evaluation of medical devices’ provides a methodical approach to evaluate biological compatibility and for the chemical characterisation of medical devices and combination products within a risk managed framework. The standard considers testing to characterise materials of construction, including degradation and toxicity testing for various endpoints. 

The term medical device covers a vast range of products from scalpels and sticking plasters to spinal implants and heart valves. When a medical device is combined with a medicinal product, however, it becomes what is labelled a combination product or drug-device combination (DDC) according to the European Medicines Agency (EMA). Examples of combination products include, but are not limited to, autoinjectors, prefilled syringes, infusion pumps, inhalers, coated stents, and many more.

Smithers has a proven track record of supporting clients with successful submissions to meet the requirements of the ISO 10993 standard for the biological evaluation of medical devices in the UK, USA, Europe, and the rest of world. Smithers is knowledgeable of and works to standards of the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom, the European Medicines Agency (EMA) in Europe, and the Food & Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER), and Center for Drug Evaluation and Research (CDER) in the United States. 

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