Tag Archives: IVDR

MDR/ IVDR CLINICAL EVALUATION TOOLKIT; PART I

After a long period of waiting, several delays, and the MDR deadline without proper guidance hanging above our heads like the Sword of Damocles, as of end of April we have one more year until MDR date of application and … Continue reading

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THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES

The medical device regulatory environment in Europe is moving, but not always as timely and as clear as one would wish, certainly not from clinical perspective. The MDR/ IVDR Rolling plan has been updated and mentions clinicals a few times, … Continue reading

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Clinical evidence under the EU Medical Device Regulation: More firework on the way.

The EU Medical Device Regulation (MDR) and the In Vitro Diagnostic device Regulation (IVDR) entered into force, local governments published guidance how to deal with the new medical device regulations, there is debate on the implementation of the MEDDEV 2.7/1 … Continue reading

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