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  • Regulatory House

Implications of MDR on the availability of medical devices

The new legislation that came into force for medical devices in May 2021 has also presented difficulties. These include a lack of certification authorities, but also significantly increased costs for certification according to the MDR regulation. Some manufacturers may decide to completely withdraw their devices from the market in view of the high costs of this process and the deadline for obtaining certification under the MDR by 26.5.2024. Others have already started the certification process, but due to the capacity of the notification authorities, certification may take much longer (18 months to 2 years).


However, the good news for Czech manufacturers is that certification of some medical devices under the MDR is already being carried out by the first Czech notification body - ITC Zlín.


We will continue to monitor how the situation develops.


Source (available only in Czech language)

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