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MEDICAL DEVICES: CHANGES IN CLINICAL INVESTIGATIONS FOLLOWING THE MDR
ENSURING MEDICAL DEVICES COMPLIANCE WITH THE MDR
The Medical Device Regulation (MDR) 2017/745, which was adopted in April 2017 came into effect in the European Union on 26 May 2021.
It replaces the existing Directives 93/42/EEC and 90/385/EEC and significantly reinforces key elements of the existing directives, such as conformity assessment procedures, clinical investigations and clinical evaluation, vigilance and market surveillance, whilst introducing provisions ensuring transparency and traceability regarding medical devices in order to improve patient safety.
When placing medical devices on the market, manufacturers shall ensure that their products have been designed and manufactured in accordance with the MDR requirements.