Biocompatibility Testing for Medical Devices

Demonstrating the safety of medical devices is a critical step in the regulatory pathway, and biocompatibility testing for medical devices plays a vital role in this process. If a device comes into direct or indirect contact with a patient, manufacturers must ensure that all materials used are safe and do not pose unacceptable health risks.

This includes assessing both the materials used in manufacturing and any substances involved in production that may come into contact with patients. Medical device biocompatibility testing begins early in the design and development phase, typically starting with a biological safety risk assessment.

Building on the biocompatibility testing for medical devices, manufacturers must assess key factors, including:

• The materials that may come into contact with the patient.
• The duration of contact.
• The level of invasiveness (e.g., short-term topical use versus permanent implantation).

Regulatory jurisdictions may lay down legislations that prohibit or limit the use of certain materials, such as those containing DEHP ((EU) 2023/2482) per July 2030.

Based on the known characteristics, prior biocomp testing, and available literature, the manufacturer needs to evaluate the need for further biological safety evaluation per ISO 10993-1.

This evaluation is unique to each medical device (or family) and requires meticulous planning and documentation. Clear rationales must be provided to demonstrate compliance, ensuring the device is biologically safe for human use and meets regulatory expectations.