The MD Regulation (EU 2017/745), fully applicable from May 2021, defines the obligations of the medical device manufacturers for the risk management system. The key element in the risk management system is to identify the hazards associated with the medical device and further assess the risks, for example, the health risks, caused by the product.
Assessing the biological safety is a part of a medical device’s risk management
An essential part of the risk management process is the assessment of biological risks for devices that are in direct or indirect contact with the patient or user. Depending on the device, several contact types may be relevant to consider; for example, the mask used in the ventilator system is in direct contact with the patient, while the tubing is not in direct contact with the patient, but instead has indirect contact with the patient because the respiratory gases are passed along the tubing to the patient.
The process for biological hazard identification and risk assessment is called biological safety evaluation. Often this means an evaluation and testing process based on the ISO 10993 standard.
Like clinical evaluation, also the biological safety evaluation is one of the elements of the MD Regulation, which is subject to many new and more clearly defined requirements. The biological safety assessment plan and report are therefore a key part of the product’s technical documentation.
A trustworthy assessment of biological safety requires versatile expertise.
Biological safety evaluation is a multi-step process that requires specific expertise. The extent of the safety evaluation depends on the type and intended use of the medical device, but evaluation must include all available relevant information on the medical device, or its constituents or degradation particles released during the use of the device. It is the responsibility of the manufacturer to identify all hazards and risks associated with the medical device and to take appropriate risk management measures to reduce risks to an acceptable level.
To reliably identify and evaluate biological hazards, specific toxicological expertise and knowledge of the hazard and risk assessment process for chemicals play a crucial role. Specific hazardous chemicals, such as carcinogens, mutagenic and reproductive toxicants, nanomaterials, and potentially endocrine disrupting chemicals, should be identified and taken into account in particular when assessing the health hazard of a medical device.
It is crucial for the end user and to the manufacturer of the medical device to be able to reliably identify the health hazards and risks associated with the device and to minimize potential risks through effective risk management methods.
We at DRA have experienced professionals to guide you through the biological safety evaluation process; we can help your company with biological safety evaluation plans and reports and be there for you to support you on the material selection for your device. In case you may have any questions related to biological safety of medical devices, please don’t hesitate to contact DRA’s Health Tech-team!
Author Jaana Palomäki is a toxicologist who specializes in nanotoxicology. She has years of experience in hazard and risk assessment of chemicals.