Claigan Webinar – EU MDR – Sensitization
Managing Sensitizers and Allergens in Medical Devices
OTTAWA, ON, Oct. 3, 2022 /CNW/ – On 12 October 2022, Claigan Environmental Inc. (www.claigan.com) 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 and Sensitizers
Date: 12 October 2022
Time: 10am and 2pm EST
Duration: 1 hour plus Q&A
To Register: https://attendee.gotowebinar.com/rt/828181171468715533 or on Claigan Website at www.claigan.com/webinars
Register now or send an e-mail to [email protected]. For more information on Claigan Environmental’s restricted materials services – see Claigan’s services at www.claigan.com
About Claigan Environmental (www.claigan.com)
Claigan is the leading provider in restricted materials compliance for EU MDR Claigan has tested thousands of products for EU MDR, REACH, and related global compliance and being the technical support for numerous Prop 65 notice defences. Claigan is an ISO 17025 certified laboratory and is dedicated to providing practical solutions for supply chain due diligence and social responsibility. At Claigan, we believe in ‘More Results. Less Journey.’
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SOURCE Claigan Environmental Inc.
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