It is the traditional summer break in Europe. But the volume of concerns being expressed by medtech players around the Medical Device Regulation’s 26 May 2024 compliance deadline is increasing.
The Hard Deadline
Manufacturers of medical devices and of many IVDs, including of new and legacy products, have a hard deadline of 26 May 2024 to comply with under the new EU Medical Device and IVD Regulations. Many are leaving compliance efforts so late that the size of the notified body bottlenecks will mean some will fail to be certified in time. Those that miss the cut-off will need to be removed from the market until they are declared compliant. That will be the case unless actions are taken by the commission to address this predicted scenario for many products.
Stakeholders are fearful that many products will remain uncertified under the new regulation’s still-tight timelines, often due to system failures...
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