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All MDD Certificates Expire May 26th, 2024


How to Prepare

  • Complete NB MDR applications ASAP for any products you intend to extend for MDD. Submissions must occur by May 26th, 2024, for those devices to be eligible for extension.
  • Ensure your supply chain controls will not allow import (including returns) into the EEA of devices with an expired certificate.
  • If extending devices using MDR Amendment 2, make sure that countries outside the EEA are aware so they can update their local licenses to take advantage of the extension period.

Contact:

Tracy Eberly

President & CEO

[email protected]

612.230.9909

About Fang Consulting

Established in 1999, Fang Consulting provides Regulatory Affairs and Quality Assurance consulting services to medical device manufacturers. From start-ups to global industry leaders, our established presence ensures efficiency, covering both pre-market and post-market device phases. We assist clients in navigating the complex nature of the regulatory landscape. Fang Consulting ensures compliance with medical device laws and regulations in every geography throughout the product lifecycle.

Contact Fang Consulting at 612.230.9909 to learn about how our team can assist your company in navigating Regulatory-related issues.

Media Contact

Tracy Eberly, Fang Consulting, 1 (612) 230-9909, [email protected], https://www.fangconsulting.com/

Asia Enger, Fang Consulting, 1 6127356559, [email protected], https://www.fangconsulting.com/

SOURCE Fang Consulting

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