With the deadline for compliance quickly approaching on May 26, 2021, understanding the EU MDR’s new requirements for medical devices is essential to maintaining market access.
TORONTO (PRWEB) March 19, 2021
Amidst a constantly-changing global regulatory landscape, swiftly and successfully adapting to the latest regulatory changes is important to ensure medical device companies’ ability to market their devices compliantly without disrupting market access.
In 2017, the European Union adopted a new regulatory framework for medical devices, Medical Device Regulation 2017/745 (EU MDR 2017/745). With the deadline for compliance quickly approaching on May 26, 2021, understanding the EU MDR’s new requirements for medical devices is essential to maintaining market access.
One of the most significant changes to the EU’s new medical device regulatory framework are new standards for medical device labeling, as well as safety, block chain and other areas.
In this webinar, the panelists will succinctly explain changes in the EU MDR’s labeling requirements, common challenges and important considerations for medical device companies when complying with the EU MDR’s new labeling translation regulations, and how language service providers can ensure medical device companies leverage best practices to ensure all labelling, safety data, and other important aspects are compliant with EU MDR 2017/745 guidelines.
Join experts from CSOFT Health Sciences Mattias Schroeter, Business Development Director and Di Lv, Chief Life Science Practice Lead & Executive Director, in a live webinar on Friday, April 9, 2021 at 11am EDT (4pm BST/UK) to learn more about the EU MDR’s labelling and other requirements for medical devices.
For more information, or to register for this event, visit How to Successfully Navigate New European Medical Device Labelling Compliance.
ABOUT CSOFT HEALTH SCIENCES
CSOFT Health Sciences provides end-to-end medical translation services for all phases of the product lifecycle, from pre-clinical to post-launch. We also specialize in market access consulting, medical writing, and CTD/eCTD submissions with the FDA, EMA, and NMPA. Our operations are compliant with ISO 17100 and certified in ISO 9001:2015 and ISO 13485:2016, ensuring our customized solutions meet the rigorous regulatory requirements of global submissions.
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