Biological evaluation of medical devices

By Paolo Pescio and Alessandro Radici, Eurofins Biolab, Italy

To date, the medical devices market is one of the most dynamic and active in the world, and everyday many new products are designed and then released to the marketplace. Many of these new products are aimed to be in direct contact with patients; therefore thorough safety assessment of the new devices is a critical step during the design and marketing process.

A medical device is generally defined as any instrument, material, apparatus for humans with a medical purpose and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means. Whereas in those cases, it will be a bio/pharmaceutical product.

One of the most relevant requirements each device has to comply with is the compatibility between the materials used and biological tissues. This property is often called biocompatibility, and it is assessed through a biological evaluation process. The biological evaluation of a device is usually based on international standards of the ISO 10993 series, together with different guidelines adopted in different countries around the world.

The biological evaluation is a structured programme in which the choice of tests shall take into account the chemical composition of the materials, including the conditions of exposure as well as the nature, degree, frequency and duration of exposure of the device to the patient.

Eurofins has had the opportunity during the past several years to develop sound experience in biocompatibility testing and can fulfil all the possible analytical needs of a manufacturer while evaluating a device thanks to its accredited world-class labs.

Eurofins experts participate in international ISO groups in charge of the development of the standards, enabling
scientists to continually be updated and aware of current and future regulatory and technical status pending changes.

Contact: GMP_EU@eurofins.com