Claigan's Upcoming Webinar: Key Changes in EU Medical Device Regulations by 2028
On April 8, 2026, Claigan Environmental Inc. will host an informative webinar that highlights significant changes to the EU Medical Device Regulation (EU MDR) which are crucial for companies engaged in manufacturing and distributing medical devices within the EU. As part of these updates, over 50 substances will be introduced that require immediate attention from industry stakeholders to maintain compliance and continued market access.
The new regulations will require device registrations to include 40 new substances deemed as Carcinogens, Mutagens, and/or Reproductive Toxicants (CMRs), alongside 10 newly classified allergens. Each year, the European Union revises its classifications of substances in alignment with the Adaptation to Technical Progress (ATP) under the Classification, Labelling, and Packaging of Chemicals Regulation (CLP). These revisions are vital as they directly affect the compliance measures for medical devices.
Key topics this webinar will cover include:
Given the anticipated interest in these updates, Claigan has scheduled two sessions on the same day—one at 10 AM and another at 2 PM (ET)—to accommodate all interested parties. Each session will run for about an hour, inclusive of a Q&A round to address specific queries from attendees. It's recommended to register early as spaces are likely to fill up quickly.
For those interested in participating, registration links have been provided: 10 AM session Register Here and for the 2 PM session Register Here. Alternatively, additional information can be found on Claigan's official website at www.claigan.com/webinars.
As the leading provider in the area of restricted materials compliance, Claigan Environmental provides expertise in consulting and testing to ensure that products are compliant with various regulations such as EU MDR, REACH, and others. Their commitment to delivering practical solutions assists companies in maintaining responsible supply chains and fulfilling social responsibilities effectively. Join them to navigate the complexities of the new EU MDR updates and ensure your products are compliant and safe for the market.
The new regulations will require device registrations to include 40 new substances deemed as Carcinogens, Mutagens, and/or Reproductive Toxicants (CMRs), alongside 10 newly classified allergens. Each year, the European Union revises its classifications of substances in alignment with the Adaptation to Technical Progress (ATP) under the Classification, Labelling, and Packaging of Chemicals Regulation (CLP). These revisions are vital as they directly affect the compliance measures for medical devices.
Key topics this webinar will cover include:
- - Identifying New Carcinogens: The presentation will delve into the specifics of 11 new CMRs introduced under ATP 23 and 29 new CMRs from ATP 24. This knowledge is essential for manufacturers to meet the safety standards set forth by regulations.
- - New Allergens: More importantly, the webinar will also cover the introduction of 10 new allergens, which are crucial for patient safety. These allergens must be prominently displayed in the labeling and user instructions of each medical device.
- - Risk Assessment: Participants will learn how to conduct risk assessments to determine the applicability of these new substances to their medical devices effectively. Understanding which materials and components pose risks will enhance product safety and compliance.
- - Standard Testing Limitations: A major concern highlighted will be the standard sensitization tests under the EU MDR, which may not be valid for these new allergens. This poses a significant challenge, as manufacturers must recognize that traditional methods of testing may not cover these newly classified allergens adequately.
- - Compliance Strategies: Claigan will discuss various compliance strategies that companies can implement to navigate these updates successfully. Ensuring compliance is not just about adhering to regulations but also about promoting safety and maintaining consumer trust.
Given the anticipated interest in these updates, Claigan has scheduled two sessions on the same day—one at 10 AM and another at 2 PM (ET)—to accommodate all interested parties. Each session will run for about an hour, inclusive of a Q&A round to address specific queries from attendees. It's recommended to register early as spaces are likely to fill up quickly.
For those interested in participating, registration links have been provided: 10 AM session Register Here and for the 2 PM session Register Here. Alternatively, additional information can be found on Claigan's official website at www.claigan.com/webinars.
As the leading provider in the area of restricted materials compliance, Claigan Environmental provides expertise in consulting and testing to ensure that products are compliant with various regulations such as EU MDR, REACH, and others. Their commitment to delivering practical solutions assists companies in maintaining responsible supply chains and fulfilling social responsibilities effectively. Join them to navigate the complexities of the new EU MDR updates and ensure your products are compliant and safe for the market.
Topics Health）
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