Biological Evaluation

The updated standard EN ISO 10993-1:2020 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process – provides guidance on how to perform a biological evaluation of a medical device in order to establish fulfilment or relevant General Safety and Performance Requirements (GSPR).
As biological Evaluation is part of the risk management process of a device, EN ISO 10993-1 shall be used in connection with EN ISO 14971 – Medical devices-application of risk management to medical devices.

The manufacturer of medical devices is responsible for assuring biological safety for the entire device lifetime and for documenting the assessment of the identified biological and toxicological risks.

BioReg can assist you with the biological evaluation process, including chemical characterization and then summarize biological evaluation results, their interpretation and conclusion in the Biological Evaluation Report (BER) based on the Biological Evaluation Plan (BEP).
As per EN ISO 10993-1, clause 4.7, the biological Evaluation is expected to be an ongoing process over the whole lifecycle.