
Zoonosis risk management
April 26 2023
Risk management for medical devices with components of biological origin
Covid 19 and the possible transmission of bats to humans has brought the topic of zoonoses (transmission of pathogens from animals to humans) to the forefront of public interest. For medical devices with materials of animal origin, it is necessary to analyze and evaluate the zoonosis risk.
The MDR has significantly increased the focus on the requirements for the basic safety and performance of medical devices whose components include materials of biological origin.
This includes medical devices,
- produced from killed animal tissues (e.g. pig heart valves) or derivatives thereof (e.g. collagen, gelatine, chondroitin sulphate, glycerine).
- in the production of which starting materials, such as bovine serum albumin, were used
- manufactured from human tissues or cells that have been destroyed (except transplants, tissues and cells covered by Directive 2004/23).
- which were produced recombinantly in microbial cell cultures / vectors.
These vector systems can themselves be of animal or human origin or require animal materials (e.g. fetal calf serum, porcine trypsin) for optimal growth.
Risk of zoonoses and biological incompatibility
For each medical device whose components include materials of biological origin, Annex I of the MDR requires an assessment of the safety with regard to the transmission of pathogens and other disease-causing agents (e.g. toxins) and the risk of biological incompatibility. The risk of infectious agents of transmissible spongiform encephalopathy (TSE), viruses, bacteria, yeasts, fungi, parasites and unclassified pathogens must be assessed. This also applies to medical devices that consist only partially of these materials or have come into contact with them during manufacture.
It should be ensured that the risk of transmission of pathogens and a possible risk of biological incompatibilities through the use of biological material is as low as possible.

This special risk assessment complements the risk assessment according to ISO 14971 and ISO 10993-1. It identifies and analyzes the probability of transmission of transmissible agents and a possible hazard due to biological incompatibilities. It defines risk minimization measures and monitors the risk and the effectiveness of risk control.
This includes the
- Evaluation of the risk posed by the origin, procurement, testing, processing, preservation, testing, treatment, storage and distribution of the material,
- Removal or inactivation of transmissible pathogens during the manufacturing process,
- traceability and special risk management, as well as
- summarized residual risk assessment including an assessment report.
This special risk assessment is important, as patients may be immunosuppressed, non-natural infection routes may be followed through the use of the medical device and there are few or no treatment options for some transmissible pathogens. In the case of TSEs, infection of the patient always leads to death.
ISO 22442 series of standards
The ISO 22442 series of standards describes the requirements and instructions for risk management in relation to typical hazards of medical devices manufactured using materials of animal origin that are non-viable or have been killed. In addition, further regulations, directives and guidelines apply.
There is no standardization for medical devices manufactured using materials of human origin that are not viable or have been killed, or other biological substances. The risk assessment is therefore based on the legal requirements for medicinal products and corresponding guidelines. This also applies to non-European market authorization.
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Als gesetzlicher Hersteller der Medizinprodukte sind Sie für die Risikoanalyse, Risikominimierung, Risikokontrolle und Bewertung des (Rest-)Risikos verantwortlich. Unsere Expertinnen und Experten unterstützen Sie bei ihrem Risikomanagement und schätzen gemeinsam mit Ihnen den Aufwand richtig ein.
Anforderungen des Risikomanagements
The effort required for the risk management of medical devices that include biological materials depends on the type of biological material, its source, origin, processing and the intended use of the medical device. The planned marketing of the products is jeopardized without special risk management and assessment of safety in accordance with MDR Annex I.
In our series of articles on the topic of "Risk assessment of zoonoses", we therefore summarize for you what data you need to collect and evaluate on the origin, sourcing, testing, processing, preservation, testing, treatment, storage and distribution of the material, what quality requirements must be observed, how extensive a literature search should be and how much time must be allowed for a completed risk assessment.
Definitions and examples
Animal:
any vertebrate or invertebrate animal including amphibian, arthropod (e.g. crustacean), bird, coral, fish, reptile, mollusk and mammal
Tissue:
assembly of functionally similar cells and their intercellular material that together carry out a specific function like porcine heart, bovine bone, bovine ligaments and bovine pericardium, blood)
Derivatives:
products obtained from a tissue (e.g. chondroitin sulphate, collagen, gelatine, antibodies, hyaluronic acid, tallow, blood products (e.g. serum), lactose, lanolin, amino acids)
Other non-viable biological substances:
microorganisms, cell cultures