Tag Archives: Medical Device Directive

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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EU MEDICAL DEVICE STUDIES IN 2015: A YEAR OF CONTRAST?

Happy New Year! Indeed the year 2015 did become an interesting one looking at it from an EU medical device study perspective. Especially since some of the events seem to create areas for tension: More transparency on clinical data, but … Continue reading

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WHAT CLINICAL BENEFIT DO YOU WANT TO PROVE IN YOUR STUDY?

Defining the clinical benefit or the efficacy parameters for your product in a clinical study is a challenging but critical activity: Do I aim to show the effect of product itself or that of a treatment as a whole, what … Continue reading

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EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED

Last week Glenis Willmott was announced to be the new rapporteur for the Medical Device Directive revision. For me that raised the question what effect this will have on the clinical research aspects of the proposed Medical Device Regulation. Given … Continue reading

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CLINICAL EVIDENCE DILEMMAS: IS MY CLINICAL STUDY POPULATION THE RIGHT ONE?

Is my study population the right one, or in other words: Does my clinical study population represent the patients the study product is meant for? An essential question to answer when designing a clinical study to collect clinical evidence regarding product … Continue reading

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NEED FOR CLINICAL EFFECTIVENESS DATA – OPPORTUNITY FOR MEDICAL DEVICES?

The report of the ENVI workshop on the Effectiveness of Medicines and Therapies is an interesting read from medical devices perspective: Typically the regulatory developments in medicinal products precede and therefore can predict upcoming trends for medical devices, and the … Continue reading

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