Tag Archives: MDR

CLINICAL EVALUATIONS & CLINICAL TRIALS IN THE EU – TAIPEI

Posted on August 15, 2018 by

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.

Posted on January 1, 2018 by

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

Posted on February 25, 2017 by

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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EU MEDICAL DEVICE CLINICAL EVIDENCE 2016/2017

Posted on December 27, 2016 by

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

Posted on August 31, 2016 by

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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EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED

Posted on September 27, 2014 by

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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