The MDR (Medical Device Regulation) has affected us as a medical technology company for several years now. This regulation, passed by the European Parliament and the Council in 2017, aims to enhance the legal framework for medical devices and in-vitro diagnostics.The implementation of these regulations will apply from May 2021 and from May 2024 for medical devices certified under the old legal regime.
Due to several serious events, such as the COVID-19 pandemic, disruptions in global supply chains and other events, there is a risk of shortages of life-saving medical devices. To address this concern, in January of this year, the EU Commission proposed an extension of the MDR implementation deadline.
This request for an extension has now been granted. The duration of the extension depends on the risk class of the medical device and can apply until December 2028 at the latest.
You can find more information on the applicable transition periods here:
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