Claigan Webinar - A Practical Walkthrough of an EU MDR Justification Document
With detailed examples
If a medical device has a carcinogen, mutagen, or reproductive toxin (CMR) in an invasive situation, fluid path, or gas path it has to be labelled and justified under section 10.4 of the EU Medical Device Regulation (EU MDR).
With the addition of cobalt and NMP to the CMR list, the majority of invasive, fluid, or gas path medical devices are now requiring justification documents for compliance to EU MDR.
Example affected products include needles, trocars, catheters, vision systems, ventilators, endoscopes, glucose monitoring systems, stents, and dental files.
Key topics will include:
- Why cobalt and NMP are so common in medical devices
- Description and characterization
- Use and function
- Assessment of risks
- Assessment of possible and relevant alternatives
- Comparison of functionality, performance, risk, and benefits
- Timelines and deadlines
Note - due to the expected demand, there will be two (2) webinars scheduled on
Webinars - Walkthrough of an EU MDR Justification Document
Date:
Time:
Duration: 1 hour including Q&A
To Register:
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: More Results, Less Journey.
View original content:https://www.prnewswire.com/news-releases/claigan-webinar---a-practical-walkthrough-of-an-eu-mdr-justification-document-302689856.html
SOURCE Claigan Environmental Inc.
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