Tag Archives: clinical evaluation

CLINICAL EVALUATIONS & CLINICAL TRIALS IN THE EU – TAIPEI

I am very much looking forward to the Medical Device Clinical Trial Regulations and Practice Seminar in Taipei September 5th, where I will be speaking on the current EU standards regarding Clinical Evaluations and Clinical Trials as well as the … 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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EU MEDICAL DEVICE CLINICAL EVIDENCE 2016/2017

The year 2016 has been a very interesting one from clinical perspective with many developments in the EU medical device regulatory environment, and I am sure we are facing an even more interesting one coming up: The latest draft of … Continue reading

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MEDDEV 2.7/1 REVISION 4: A HIGHER DEMAND FOR CLINICAL EVIDENCE

In Europe the second quarter of 2016 is characterized by several big steps from clinical perspective: In April the General Data Protection Regulation (GDPR) entered into force, in June consensus was reached on the new Medical Device Regulation (MDR), and … Continue reading

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EUROPEAN MEDICAL DEVICE REGULATION – FIVE KEY DRIVERS OF THE PREMARKET CLINICAL EVIDENCE BASE

The Medical Device sector concerns a wide variety of products and the proposed European Medical Device Regulation attempts to regulate the pre- and postmarket clinical evidence base under one umbrella. Driven by scandals such as with the hip and PIP … Continue reading

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