With the introduction of Regulation (EU) 2017/745, manufacturers of medical devices are facing increasing challenges, also regarding the assessment of the biological safety of their products. Both the update of ISO 10993-1 in 2018 as well as the introduction of the ISO 18562 series of standards in 2017 play a major role. The biological risks are identified within a risk management system in accordance with ISO 14971 and assessed based on a scientific analysis of preclinical and non-clinical as well as clinical data. As a result, the need for additional data can be determined and any gaps in knowledge can be closed. Thus, a comprehensive database and literature research in combination with the risk management process represents a basis for argumentation for the waiver of laboratory tests, especially animal experiments, and still enables the reliable assessment of the biological safety of the materials used in the medical device.

Overall Assessment within a Risk Management System

The overall biological safety assessment starts with the compilation of a biological evaluation plan (BEP) as part of the risk management plan. The aim is to identify the biological risks of medical devices, depending on the type and duration of body contact, and to evaluate these based on available data. In this context, identified data gaps can be closed by implementing necessary analytical and / or biological testing. After the tests have been performed and the risk assessment is completed with the conduction of a benefit-risk profile, the evaluation is summarized in a biological evaluation report (BER, Biological Evaluation Report). This contributes to the general assessment of biological safety and has strategic advantages in product development as well as in market approval. The biological assessment is another essential part of the technical documentation that emphasizes the safety of your medical device. It is required by Regulation (EU) 2017/745 and ISO 14971 and, depending on the medical device, specified by ISO 10993 and / or ISO 18562.

Do you need support in assessing the biological safety of your product?

NSF PROSYSTEM GmbH has many years of experience in the field of ISO 14971 as well as the ISO 10993 and ISO 18562 series of standards and will be happy to provide you with qualified experts. Our specialists have a scientific background with laboratory experience, which guarantees a professional analysis and evaluation of preclinical and non-clinical, but also clinical data. Do not risk any security gaps or obstacles to the development of your medical device and let us advise you without obligation.
Our services in the field of biological safety evaluation include:

  • Product-specific advice and development of a strategy for assessing the biological safety of medical devices
  • Creation and updating of biological assessment plans and / or reports according to ISO 10993-1 and ISO 18562-1
  • Literature and / or database research for a scientifically based assessment of the biological safety of the medical device
  • Assessment of the available pre- and non-clinical as well as clinical data with regard to the biological safety of the medical device
  • Consideration of the biological hazards within the risk management and determination of the need for further biological tests
  • Provision of templates for the creation of biological assessment plans and / or reports
  • Training with appropriate training certificate

For further details regarding “Biological Safety” or for a non-binding offer please contact us.