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Within UL Solutions we provide a broad portfolio of offerings to all the medical device industries. This includes certification, Approved/Notified Body and consultancy services. In order to protect and prevent any conflict of interest, perception of conflict of interest and protection of both our brand and our customers brand, we have processes in place to identify and manage any potential conflicts of interest and maintain impartiality. UL Solutions is unable to provide consultancy services to EU MDD, MDR or IVDD Notified Body, UKCA MD Approved Body or MDSAP Customers.
  • On-demand Webinar

EU Medical Device Regulation (EU MDR): A Practical Approach

Learn effective and practical approaches that meet EU medical device regulation (MDR) requirements, and how to update them based on notified body feedback.

Close-up of an electrocardiogram monitor in a hospital room
THE CONTENT OF THIS WEBINAR IS FOR GENERAL INFORMATION PURPOSES ONLY AND IS NOT INTENDED TO CONVEY LEGAL OR OTHER PROFESSIONAL ADVICE.

Section of 10.4.1 of the EU Medical Device Regulation (EU MDR) requires the identification of carcinogens, mutagens, and reproductive toxins (CMRs) and endocrine-disrupting chemicals (EDCs) over 0.1% w/w in invasive, or fluid or gas contacting materials. There is no one standard format for the output requirements. 

This webinar will discuss effective and practical approaches that meet the requirements of EU MDR and how to update them based on notified body feedback.

Learning objectives:

  • What are CMRs and EDCs?
  • What CMRs and EDCs are in medical devices?
  • How to identify CMRs and EDCs in medical devices

Speaker:

Bruce Calder, vice president of regulatory, Claigan

Webinar date:

Dec. 2, 2020

Watch the on-demand webinar

EU MDR: A Practical Approach

Hospital operating room with monitors and equipment

Medtech

Healthcare technology and medical devices are constantly evolving to improve accuracy, patient safety and patient wellness. This rapid progress also leaves these devices increasingly susceptible to quality, safety and cybersecurity issues. We offer safety and compliance testing and training to take on these, and many other issues facing the healthcare device industry.

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