October 12, 2022

Managing Sensitizers and Allergens in Medical Devices

On 12 October 2022, Claigan Environmental Inc. will present a webinar on handling the sensitizers and allergens in medical devices. Historically, the 1,263 official sensitizers in the EU are handled through animal testing of extracts from medical devices. The process is time consuming, costly, and involves very frowned upon animal testing.

ISO 10993-10 has a hierarchy of processes in handling sensitizers in medical devices. Using alternative testing and engineering evaluation, the potential presence of allergens can be identified and animal testing be limited only to materials and situations where it is absolutely necessary.

Claigan’s approach to sensitizers and allergens identifies the presence of specific allergens in specific materials. This allows for animal testing to only be used in situations when there are no alternative options, and it allows for identification of allergens in specific concentrations. By knowing the specific allergens and concentrations, the manufacturer can leverage previous testing of similar allergens levels to justify reduced or no animal testing.

The main topics to be covered in this webinar are – 

• EU Medical Device Regulation (EU MDR) and Sensitizers
• High risk materials for sensitizers
• ISO 10993-10 compliance options
• Sensitizer testing
• Labelling and warnings for sensitizers

Due to the interest in these topics, two (2) webinars will be held on October 12 to accommodate a larger audience.

Webinars – EU MDR – Sensitization

Date: 12 October 2022

Time: 10am and 2pm EST

Duration: 1 hour plus Q&A