Tag Archives: clinical evaluation

2020 – THE 11th HOUR FOR THE MDR, ISO 14155, & OTHER EU CLINICAL MATTERS

  Nothing could have been more illustrative for the medical device clinical trial environment in Europe  than the storms Ciara and Dennis in February. With BREXIT as a kick off, the Coronavirus spreading around te globe, the MDR deadline less … Continue reading

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6 MONTHS LEFT UNTIL MDR: MORE TIME FOR YOUR CLINICAL EVALUATION?

Update 18-DEC-2019: The EU parliament adopted the second MDR corrigendum, giving manufacturers of Class I medical devices 4 years extra to bring their clinical evaluation in order, putting them in the same position as the other medical devices with a … Continue reading

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THE EU MEDICAL DEVICE CLINICAL ENVIRONMENT: UNCERTAIN TIMES

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

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A NEW VERSION OF ISO 14155: WHAT TO EXPECT?

The MDR as well as the current version of MEDDEV 2.7/1 reference ISO 14155 as GCP standard for medical device clinical investigations. Indeed, the 2011 version, but the third edition is in the making, so it can be good to … Continue reading

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

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

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