New extensions to implement MDR: impact on legacy devices

The new Regulation on Medical Devices (MDR) entered into force in May 2021, replacing the previous Directive. Since then, many medical devices are subject to a transitional period. The initial transitional period foresaw that medical devices certified under the Directive could be placed on the EU market until May 26, 2024, if they met legacy requirements. A new decision just changed the scenario, bringing a longer transitional period and extended validity of CE certificates.
Challenges under MDR
The implementation of the MDR could bring to various challenges, which eventually would negatively affect health systems and patients. According to the first . . .


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