OTTAWA, ON, March 31, 2026 /CNW/ – On April 8th, Claigan will present a webinar focusing on a major update to substances in scope of the EU Medical Device Regulation (EU MDR).
To maintain EU market access by 2028, device registrations must account for forty (40) new Carcinogens, Mutagens, and/or Reproductive Toxicants (CMRs) and ten (10) new allergens.
Every year, the EU updates their classification of substances under the Adaptation to Technical Progress (ATP) of the Classification, Labelling, and Packaging of Chemicals Regulation (CLP). Each update usually includes newly classified Category 1 CMRs (Cat. 1 CMRs). These Cat. 1 CMRs are regulated under section 10.4 of the EU Medical Device Regulation (EU MDR).
Additionally, this year there are ten (10) substances with new scientific agreements as allergens in medical devices. Allergens are regulated under 23.4 (s) of EU MDR and need to be accounted for in device labelling, instructions for use, and the technical file. One of the major challenges with the known allergens is that standard sensitization tests normally conducted under EU MDR are not valid for any of these ten (10) allergens.
Key topics will include:
Eleven (11) new CMRs under ATP 23
Twenty-nine (29) new CMRs under ATP 24
Ten (10) new allergens
Risk assessment for applicability to medical devices
At-risk materials and components
Why standard EU MDR sensitization tests do not detect these allergens
Compliance approaches
Note – due to the expected demand, there will be two (2) webinars scheduled on April 8.
Webinars – New EU MDR CMRs and Allergens
Date: 8 April, 2026
Time: 10am and 2pm
Duration: 1 hour including Q&A
To Register:
10am – https://us06web.zoom.us/webinar/register/WN_83r3JYgoTvuFqC0Vbygefw
2pm – https://us06web.zoom.us/webinar/register/WN_dGFy55LZTjWiobfowJbqDA
or on Claigan’s Website at www.claigan.com/webinars
About Claigan Environmental (www.claigan.com)
Claigan is the leading provider in restricted materials compliance (consulting and testing). Claigan has tested thousands of products for EU MDR, PFAS, Section 71, REACH, POP, TSCA, Prop 65, and related global compliance. Claigan is an ISO 17025 accredited laboratory, expert consultancy, and is dedicated to providing practical solutions for supply chain due diligence and social responsibility.
At Claigan, our philosophy is simple: Less Journey, More Results.
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