All MDD certificates are set to expire on 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.
ROSEVILLE, Minn., May 15, 2024
/PRNewswire-PRWeb/ -- Sell-Off
"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.
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
tracy@fangconsulting.com
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, tracy@fangconsulting.com,
https://www.fangconsulting.com/
Asia Enger, Fang Consulting, 1
6127356559, asia@fangconsulting.com,
https://www.fangconsulting.com/
View original content to download
multimedia:https://www.prweb.com/releases/time-is-running-out-all-mdd-certificates-expire-may-26th-2024-302146204.html
SOURCE Fang Consulting