Category Archives: Uncategorized

CORONAVIRUS AND CLINICAL STUDIES: WHAT TO DO?

By now the Coronvirus outbreak is affecting everyday life worldwide (see latest statistics Johns Hopkins University), and to avoid patient exposure or to reduce the burden on clinical services it also started impacting clinical trials; their execution, monitoring, and publications. … Continue reading

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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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