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Risk management and biological safety: A powerful team

A medical device must meet essential safety and performance requirements according to the Medical Devices Regulation (Annex I MDR 2017/745) in order to place a medical device on the market in Europe. One of these requirements is the biokompatibilität of the said Medical Device. But what does biocompatibility mean and how is the interface to risk management defined? Our expert Dr. Anja Rämisch has summarized the most important aspects for you.

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The biocompatibility review ist constantly gaining in importance because the requirements for medical devices and their safety continue to increase. To create an overview of the relevant aspects of these exciting topics for Medical Device manufacturers, we are dedicating three months to biocompatibility under the title qtec Spotlight.


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Follow us on LinkedIn to make sure you don't miss anything. As part of the qtec Spotlight series, you can expect quarterly blog posts, info events and videos from our experts.

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The basic safety and performance requirements

The basic safety and performance requirements for Medical Devices are described in the Annex I of the MDR. A distinction is made between general requirements, which concern, among other things, risk management, requirements for the information supplied with the product, and requirements for both interpretation and safety. Essential safety requirements are, for example:

  • Materials should be selected with respect to physical and toxicological properties
  • Materials used should be compatible by themselves and in combination with contact tissues, cells and/or body fluids.

The risk of harmful substances and possible contamination from manufacturing and packaged product should be kept as low as possible for the patient and/or user.

The interfaces between risk management and biocompatibility

The assessment and evaluation of potential health hazards and their probability of occurrence for medical devices is the responsibility of risk management. The process of risk management is described in ISO 14971, which was recently revised and last published in 2020. However, it is not a matter of being able to exclude every risk, but of identifying, assessing and controlling every risk.

The biological safety assessment represents an essential part of the risk assessment. It examines and evaluates potential biological risks (e.g. irritation, sensitization, cancer risk, systemic effects) emanating from the materials used and potential impurities or degradation products. The primary focus here is on the risk to the patient. In some cases, however, the risk to the user may also be considered, namely when the products are also intended to protect the user (e.g., examination gloves, FFP2 masks).

The approach of biocompatibility assessment is described in the ISO series of 10993 standards. Basic principles of risk assessment, as described in ISO 14971, are also applied here. For example, the approach for biological assessment should be planned and recorded in a biological evaluation plan. Likewise, the biological assessment includes the important milestones of a risk assessment: risk analysis, risk evaluation and risk control (see Figure 1).

Biocompatibility over the entire life cycle

Since the biological safety of a medical device needs to be ensured throughout its entire live cycle, clinical data and post market surveillance data are an important tool for risk assessment. Here, the risk management team provides an important interface between clinical evaluation, post market surveillance (PMS) and biological safety. Thus, occurrence probabilities of incompatibilities from clinical evaluation data or PMS data of comparator products can be used for the biological evaluation.


Challenge first biocompatibility assessment

The initial biocompatibility assessment of your medical device can be particularly difficult. Which substances are critical and which threshold values from the literature should be applied? Our experts have an answer to even the trickiest questions.

Contact +49 451 808 503 60

The requirements for demonstration of biological safety have increased significantly with the revision of ISO 10993-1 (2018) published, and require a high level of knowledge and experience of the evaluators at least in chemistry and toxicology. The latest revision introduced, among other things, new "first choice" test methods to save animal testing and expanded the aspects of a biocompatibility assessment to be considered.

A well-established communication exchange between the risk management team and the biocompatibility evaluators is critical to successfully launch and maintain a medical device on the market.

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