FOR IMMEDIATE RELEASE
May 15, 2024
Time is Running Out: All MDD Certificates Expire May 26th, 2024
Roseville, MN, 05-15-2024 – All MDD certificates are set to expire May 26th, 2024. To continue manufacturing devices after this date with a CE mark, OR to import them into the EEA, devices must either have an MDR certificate OR have an MDD extension per MDR Amendment 2.
“Companies need to track their MDD products currently selling in the European Union and understand that anything restocked after May 26th needs to be MDR compliant.” said Tracy Eberly, CEO of Fang Consulting.
Sell-Off
Within the EEA, MDD products that have already been placed on the market may continue to be sold or put into service indefinitely unless limited by shelf-life/ expiration date. Selling off to countries outside the EEA will depend on the local market requirements and must be assessed individually. Please note that there are countries outside the EEA that also require MDD products to be placed on the market prior to 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
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.
