Tag Archives: Clinical Investigation

THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES

Posted on April 7, 2019 by Annet Muetstege

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 →

Posted in Uncategorized | Tagged Brexit, clinical evaluation, Clinical Investigation, clinical studies, IVDR, MDCG, MDCG guidances, MDR, MDR Rolling Plan, Medical Devices, Postmarket Safety Reporting, Premarket Safety Reporting | Leave a comment

MEDICAL DEVICE CLINICAL EVIDENCE HIGHLIGHTS 2018/ 2019: ROARING TIMES IN EUROPE

Posted on January 2, 2019 by Annet Muetstege

From a medical device clinical evidence perspective, we are looking back on a turbulent 2018 and forward to an exciting 2019. Highlights of 2018 included, the GDPR becoming effective, with more strict regulations on data handling and the content of … Continue reading →

Posted in Uncategorized | Tagged clinical evaluation, Clinical Evidence, Clinical Investigation, clinical studies, clinicaltrials gov, Europe, MDR, MEDDEV 2.7/1, Medical Devices | Leave a comment

THE MEDICAL DEVICE CLINICAL TRIAL ENVIRONMENT IN EUROPE

Posted on November 28, 2018 by Annet Muetstege

One of the topics discussed during the Medical Device Clinical Trial Seminar in Taipei, was the current medical device clinical trial environment in Europe and how that is evolving. A short version of my presentation, you can find on SlideShare … Continue reading →

Posted in Uncategorized | Tagged clinical evaluation, Clinical Evidence, Clinical Investigation, clinical studies, Declaration of Helsinki, ISO 14155, MDR, MEDDEV 2.12-2, MEDDEV 2.7/1, Medical Devices | Leave a comment

EU MDR – CAN YOU AFFORT TO WAIT STARTING YOUR CLINICAL TRIAL?

Posted on March 6, 2018 by Annet Muetstege

There is no debate that under MEDDEV Rev 2.7/1 Rev. 4 and the MDR there is a higher demand for qualitative clinical evidence on medical device safety and performance before and after they are brought to market (also see my … Continue reading →

Posted in Uncategorized | Tagged clinical evaluation, Clinical Evidence, Clinical Investigation, clinical studies, Clinical Trial, Europe, MDR, MEDDEV 2.7/1, Medical Device Regulation, Medical Devices, Postmarket Clinical Follow-Up, Postmarket Studies, Premarket Study | 2 Comments

EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED

Posted on September 27, 2014 by Annet Muetstege

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 →

Posted in Uncategorized | Tagged Clinical Investigation, Clinical Research, Clinical Trial, MDR, Medical Device Directive, Medical Device Regulation | 1 Comment

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

Posted on January 14, 2014 by Annet Muetstege

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 →

Posted in Uncategorized | Tagged Clinical benefit, clinical evaluation, Clinical Evidence, Clinical Investigation, Clinical Trial Investment, Efficacy, MDD, MDR, Medical Device Directive, Medical Device Regulation, Medical Devices, Randomized Controlled Trial, RCT | 2 Comments

WHERE WILL THE EU MEDICAL DEVICE REGULATION LAND FOR CLINICAL TRIALS?

Posted on February 23, 2013 by Annet Muetstege

The proposed EU medical device regulation is designed to lead to better clinical evidence and improved patient safety. Measures such as the scrutiny procedure, improved postmarket surveillance and vigilance, and more devices being classified as high risk, should prevent disasters … Continue reading →

Posted in Uncategorized | Tagged Clinical Evidence, Clinical Investigation, Clinical Research, Clinical Trial, Country Regulations, Ethics Committee, ISO 14155, Medical Device Directive, Medical Device Regulation, Medical Devices, Postmarket Clinical Follow-Up, Postmarket Safet Reporting, Postmarket Surveillance, Premarket Safety Reporting, Vigilance | 1 Comment

Tag Archives: Clinical Investigation

THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES

MEDICAL DEVICE CLINICAL EVIDENCE HIGHLIGHTS 2018/ 2019: ROARING TIMES IN EUROPE

THE MEDICAL DEVICE CLINICAL TRIAL ENVIRONMENT IN EUROPE

EU MDR – CAN YOU AFFORT TO WAIT STARTING YOUR CLINICAL TRIAL?

EU MEDICAL DEVICE DIRECTIVE REVISION CONTINUED

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

WHERE WILL THE EU MEDICAL DEVICE REGULATION LAND FOR CLINICAL TRIALS?

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