Category Archives: Uncategorized

DUTCH HEALTH INSPECTION – THE 4 KNOWS OF THE CONFERENCE ON CLINICAL TRIALS WITH MEDICAL DEVICES

The Dutch Health Inspection (IGZ) organized an invitational conference on clinical research with medical devices end of last year. Representatives of the different stakeholders, such as manufacturers, competent authorities, Ethics Committee’s, and health care providers were present during this conference … Continue reading

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INFORMED CONSENT – 5 CRITICAL ELEMENTS TO MONITOR

Ensuring proper informed consent in clinical studies is a critical process, that protects the rights, safety, and welfare of human subjects involved. It will require even more attention under the new GDPR and with the globalization of clinical trials. Although … 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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MUTUAL ACCEPTANCE OF CLINICAL STUDY DATA IN DAILY PRACTICE

During the congress on clinical trials for medical devices in Berlin, I spoke on the mutual acceptance of clinical trial data. A short version of my presentation you can find on SlideShare: Globalization of Clinical Trials: Mutual acceptance of Medical … Continue reading

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GENERAL DATA PROTECTION REGULATION – 5 CLINICAL ASPECTS

As mentioned in my previous post on the MEDDEV 2.7/1 revision 4, the second quarter of 2016 is characterized by several big steps from clinical evidence perspective: Besides the publication of the new version of the MEDDEV 2.7/1, consensus was … Continue reading

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GLOBALIZATION of MEDICAL DEVICE TRIALS: MUTUAL RECOGNITION of CLINICAL STUDY RESULTS

I am looking forward to the International Congress on Clinical Trials for Medical Devices in Berlin later this month, where I will be talking about the globalization of clinical trials and mutual acceptance of foreign clinical data for regulatory and … 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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