🚨 Countdown for MDR Certification: Imminent Deadline for Legacy Devices!
If your medical device is not yet fully compliant with the Medical Devices Regulation (MDR), retaining «legacy device» status is crucial to continue placing your products on the EU market. Article 120 of the MDR outlines key deadlines that must be met.
📅 Upcoming Deadline: 26 September 2024
By 26 September 2024, you must have a written agreement with a notified body to obtain MDR CE certification for your legacy devices. By 26 May 2024, you should have submitted an application to the notified body, which needs to be formalized with this written agreement.
🔍 Key Requirements to Maintain Legacy Device Status:
- MDR Application: Submit by 26 May 2024.
- Quality Management System (QMS): Must be in place by 26 May 2024.
- Ongoing Compliance: The device must comply with the applicable Directive and must not undergo significant changes in design or intended use.
- Safety and Surveillance: The device must not present unacceptable risks and must comply with MDR requirements for post-market surveillance.
🔄 What to Expect After 26 September 2024: Only the notified body for MDR certification will be authorized to perform surveillance activities. The «outgoing» notified body will collaborate with the MDR notified body to ensure a smooth transition of surveillance activities.
📞 Need assistance with these requirements? Contact us for personalized support and ensure your devices are compliant and ready for the future.
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