EN ISO 22442 applies to all medical devices except for in vitro diagnostic devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. Thus not only medical devices made of materials of animal origin are considered but also medical device that might be in contact with products of animal origin during manufacturing process. This could be e.g. cleaning equipment as well as lubricants. EN ISO 22442 series is not limited to risks associated with viruses and agents causing transmissible spongiform encephalopathy (TSE), but also includes bacteria, molds, yeast and parasites that infect the animal of origin and might infect humans as well. Furthermore it is focused on the supply chain of the medical devices beginning from the health and husbandry of single animal to the medical devices’ batch. MDR specifies and redistributes the responsibilities of notified bodies and manufacturers. While ISO 22442-1 will be adapted to MDR the FDA published the guidance on medical devices containing materials derived from animal sources (except for in vitro diagnostic devices) in March 2019.
This training will provide medical device manufacturers with helpful information on the challenges, pitfalls and solutions for approval or recertification of medical devices manufactured utilizing materials of animal origin.
- Background information on changes in MDR
- Background information on further applicable European regulations and commission decisions
- Background information on requirements for FDA approval
- Detailed information on zoonotic diseases and the causing germs and TSE agents
- Risk analysis and mitigation
- Inactivation methods and verification of inactivation
- Information on the approach, the content and the structure of expert statements for fulfilling the requirements of EN ISO 22442, MDR and FDA guidance