Basic knowledge of animal-derived materials in medical devices

The webinar, organized in collaboration with the notified body TUV SUD, will provide guidance on the regulatory process for the certification of a medical device containing animal-derived components. Although specialized, this webinar aims to provide medical device manufacturers with useful knowledge to initiate their regulatory journey. 

Goal of the webinar 

The main goal is to provide an overview of current regulations and requirements for the use of animal materials, with a specific focus on materials from species at risk of TSE, in medical devices. 

The webinar will present which animal-derived materials are subject to, or exempt from, GSPR 13.2 of the MDR and provide insights into how to interpret its regulatory requirements. The sesson will highlight the importance of understanding the ISO 22442 series of standards and the consultation process with the competent authorities of the European (TSE-relevant materials) - including timelines and procedures. 

Program 

The course will cover the following topics:

• Examples of animal medical devices 
• General introduction to animal pathogens, TSEs, and zoonotic diseases 
• Current EU regulatory framework: MDR / MDCG
• EN ISO 22442 series 1,2,3 
• Regulation 722 2012 (TSE-relevant species)
• Q&A

Useful information  

Duration: 11:30 am - 12:30 pm 

Delivery mode: online 

Course language: italian