Update of Biocompatibility Documentation

Why:

The case study should cover the major points involved in updating biocompatibility documentation that need to be taken into consideration with the help of a case report. An update of the biological safety documentation was conducted for a company developing medical devices used in dentistry. The product under assessment had already been on the market for more than 15 years. Some biological safety testing was conducted in the past under previously valid guidelines and standards. By the evaluation of already existing data and comparing it to the currently requirements for biocompatibility assessment, unnecessary testing could be avoided, which subsequently would lead to a reduction of costs and time.

For whom:

The case study is designed for a medical device manufacturer handling an update of the biological safety evaluation; for example, in the context of the MDR transition or the general approach of placing their products on new markets.

How:

A device-specific GAP-assessment was generated by our biocompatibility experts to evaluate the necessity of additional information to be implemented within the biological safety evaluation. A detailed assessment of all available information (including performed biological safety testing, clinically relevant data, toxicological assessments, etc.) was conducted. Among others, the document focused on the following key aspects:

1. Evaluation of the currently valid endpoints according to ISO 10993-1 potentially necessary for fulfilling a state-of-the-art biological safety assessment were evaluated.
2. Additional vertical standards (ISO 7405) for medical devices used in dentistry were considered as well as additional aspects of the MDR and FDA Guidance document.
3. Validity check of the available ISO 10993 testing to assess the applicability of those study reports.

Not all biological endpoints were considered in the past and some of the performed biological safety tests did not fulfill the most up-to-date versions of the applicable guidance.

The experts discussed each individual endpoint based on the available data set. Although the study reports of the chemical characterisation and the cytotoxicity test did not cover the current applicable requirements of the respective guidelines, a state-of-the-art comprehensive evaluation and additional toxicological risk assessment was conducted. In the context of the GAP-Assessment, an additional testing for sensitisation was necessary based on the available information. Direct communication with the client and a detailed description of the experimental set up, including extraction parameters, facilitated the further testing procedure.

With the help of this procedure, the experts were able to prevent unnecessary testing and provide scientifically justified rationale by taking all available information for the safe clinical usage as well as the biological safety aspects into account. Ultimately, a complete assessment of each endpoint was implemented either by available testing or by describing the respective rationale for the omission of testing.

Outcomes:

Comprehensive assessment of all available information in the context of an update of the biological safety evaluation prevented the carrying out of unnecessary testing and thereby saved money, time, and animals while facilitating the recertification of the device.