By 26 May 2024, manufacturers must have an MDR compliant Quality Management System in place and have lodged an application with a Notified Body. Therefore, it is imperative for companies with legacy devices to take immediate action and secure a formal agreement with an NB to ensure a smooth transition and to avoid disruptions to their ability to market their devices within the EU.
What do I need to do for my medical device or IVD to be compliant?
Receiving formal acceptance from the notified body is an important milestone in the regulatory process for manufacturers, as it signifies that their application has been successfully received. By 26 September 2024 a signed agreement between the Notified Body and the manufacturer needs to be in place. Only in case these conditions are met manufacturers can benefit from the extended MDR transition timelines.
We understand the importance of this transition for your business and are here to support you every step of the way. Please do not hesitate to contact us if you have any questions or require further assistance.
Learn how MedEnvoy can assist you:
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