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Upcoming Webinar on EU MDR Changes: Stay Compliant By 2028

On April 8, Claigan Environmental is set to host an informative webinar that focuses on significant changes being implemented in the EU Medical Device Regulation (EU MDR). This update affects the registration processes for many medical device manufacturers as they prepare to incorporate 50 new carcinogens, mutagens, and reproductive toxicants (CMRs), along with 10 new allergens. These changes will be crucial for maintaining market access in the EU by the 2028 deadline.

Understanding the Updates

Every year, the European Union updates its chemicals classification through adaptations to the Technical Progress of the Classification, Labelling, and Packaging (CLP) of Chemicals Regulation. This year’s updates will include:

• - 11 new CMRs under the Adaptation to Technical Progress (ATP) 23
• - 29 new CMRs under ATP 24
• - 10 new allergens that must be taken into account

Medical device manufacturers will need to ensure that their products and documentation meet these new requirements. With allergens, it's particularly challenging because regular sensitization tests may not be reliable for the newly identified allergens, as these have not been previously classified in accordance with EU MDR regulations.

Key Topics to Be Discussed

Participants can expect detailed discussions on several key subjects:

• - An overview of the newly classified CMRs under the EU MDR
• - The implications of the new allergens on product labelling and instructions for use
• - Best practices for risk assessment when dealing with at-risk materials and components
• - Comprehensive strategies to ensure compliance with these new regulations
• - An exploration of why standard sensitization tests are ineffective for the newly classified allergens

Webinar Schedule

Due to anticipated demand, Claigan will hold two sessions on the same day:
1. 10 AM EST
- Register Here
2. 2 PM EST
- Register Here

About Claigan Environmental

Claigan Environmental is a recognized leader in assisting companies to comply with regulations regarding restricted materials. With a track record of testing thousands of products against numerous compliance standards, Claigan operates as an ISO 17025 accredited laboratory and expert consultancy. Their mission is to provide practical solutions for businesses to navigate the complex framework of global compliance and supply chain responsibility.

For more information or to register for the webinar, please visit Claigan's official website. Join the webinar to ensure your compliance strategies are updated and meet the new EU MDR standards.

Stay ahead in the medical device industry by understanding these fundamental regulatory changes before the 2028 deadline.