REGULATORY ALERT—MDD Certificate Extension
Date: 2023.12.18
Regulatory Alert Number: RA-2023-011
World Class Technology Corporation (WCT) has lodged a formal application for an extension of our Medical Device Directive (MDD) per EU 93/42/EEC with our Notified Body as part of the Medical Device Regulations (MDR) per EU 2017/745 as extended by EU 2023/607. This means that our devices that are currently CE marked under certificate DD 2234074-1 will continue to be placed on the market after the expiry date of 2024-05-26 if certain conditions are met. WCT is aware of these conditions and will continue to meet them for as long as needed.
The regulations are clear that Notified Bodies cannot issue new MDD certificates during the implementation of the MDR and in order to avoid disruptions in the market, manufacturer’s may declare their legacy devices meet the transitional conditions until the new MDR implementation date of 2028-12-31 or until an MDR certificate is issued, whichever comes first.
Please reference EU regulation 2023-607 at EUR-Lex - 32023R0607 - EN - EUR-Lex (europa.eu) for additional details if needed.
Please contact WCT International Sales Operations at ashley.s@worldclasstech.com if you have any questions or need further information.
Sara Runnels
Quality Management and Regulatory Affairs Manager
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