Biological & chemical evaluation

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Biological & Chemical Evaluation

There is an increasing focus on biological and chemical characterization both in the EU and FDA.

Companies should distinguish between material characterization, which mostly includes listing all constituent chemical processing agents, and chemical evaluation. In the latter, the product is exposed to extraction conditions, and this extract is subjected to various analytical tests to detect BoCs, semi-BoCs, organic compounds, etc. ISO 10993-1 Table A1 is a prerequisite for all biological endpoint-based testing.
ISO 10993-1 (2018) and EU- MDR require chemical characterization (performance or its consideration). Until now, legacy devices haven’t done chemical characterization
The purpose of ISO 10993-1 is as much as possible to reduce biological endpoint-based testing.

We advise companies not to use chemical characterization for cytotoxicity, irritation, sensitization, pyrogenicity, hemocompatibility, and some implantation tests.
According to ISO, chemical characterization is a prerequisite input for your risk assessment, based on which you decide which biological endpoint test to perform.
Chemical characterization also serves as a baseline for your device in relationship to your future models and could be compared to.

You probably don’t need to perform extractable and leachable (E&L) for the transient devices. However, if you want to claim equivalence to other devices and some material differences exist – you might need to do E&L to show the equivalence.

Even if you performed all ISO 10993-1, the reviewer will probably ask to see chemical characterization. The extent of chemical characterization will depend on the duration of contact.
For the lower-risk devices, you can try only material characterization (without chemical evaluation). You should prepare a list of all ingredients with their CoA. In addition, all processing agents used during the manufacturing process should be included, as well as literature data references and safety data for these ingredients.
For the intact skin surface, you will most probably need to perform cytotoxic, irritation, and sensitization tests, but the chemical characterization is a prerequisite for any biological tests, which is the basis of your risk management.

You can use a chemical characterization instead of genotoxicity or chronic toxicity. You should consult standard ISO TS 21726 – 2019.

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 fulfillment or relevant General Safety and Performance Requirements (GSPR).
As biological assessment is part of a device’s risk management process, EN ISO 10993-1 shall be used in connection with EN ISO 14971—Medical applications of risk management to medical devices.

The manufacturer of medical devices is responsible for assuring biological safety for the entire device’s 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, biological Evaluation is expected to be an ongoing process throughout the lifecycle.


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