Risk Assessment for Materials of Biological Origin – Inhouse Training

Successful Assessment of the Essential Safety and Performance Requirements for Products Containing Materials of Biological Origin: Requirements for Design and Manufacturing

Products containing materials of biological origin pose additional risks regarding their safety and performance due to the potential transmission of pathogens. Therefore, there are specific requirements for the design and manufacturing of these products.

Materials of biological origin include materials derived from tissues or cells of animal or human origin, or their derivatives, that are non-viable or have been killed. According to Regulation (EU) 2017/745 (MDR), this also includes products manufactured using other non-viable biological substances that are not of animal or human origin. This includes in vitro manufactured products and materials of plant origin.

If products come into contact with materials of biological origin only during manufacture, it must also be verified whether the requirements for design and manufacture are met.

Pathogens include bacteria, yeasts, fungi, parasites, viruses, and prions (the causative agents of transmissible spongiform encephalopathy). However, their metabolic products (e.g., exotoxins, enterotoxins) and components (e.g., endotoxins, surface proteins, DNA, RNA) also pose a health risk. If pathogens are transmitted by animals, this is referred to asa zoonosis. If pathogens are transmitted by plants, it is aphytosis.

In the case of iatrogenic pathogen transmission, the natural routes of transmission are often bypassed. A patient’s immune system is weakened compared to that of a healthy person. Therefore, iatrogenically transmitted infections are often not recognized as the cause ofthe deteriorating or non-improving health condition.

For materials of animal origin, special risk management in accordance with EN ISO 22442-1 is required, which explicitly addresses the specific requirements for the design and manufacture of these products. For materials of human origin, Directives 2004/23/EC and 2002/98/EC apply. The requirements for materials of other biological origin have not yet been specified by further regulations, directives, or standards. However, since the requirements for the safety of patients, users, and third parties are the same, the risk analysis and risk assessment can be conducted in accordance with the requirements of the EN ISO 22442 series of standards.

Learn how you can prevent, minimize, and control the risk of pathogen transmission right from the selection of biologically derived materials, through the supply chain, and during the manufacture of the medical device. Gain knowledge of recognized methods for eliminating and inactivating pathogens during manufacturing, thereby minimizing the risk of infection. Using examples, you will practice assessing the risk of infection according to EN ISO 22442-1 for your products and define an acceptable risk.