Tag Archives: Postmarket Studies

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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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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NEED FOR CLINICAL EFFECTIVENESS DATA – OPPORTUNITY FOR MEDICAL DEVICES?

The report of the ENVI workshop on the Effectiveness of Medicines and Therapies is an interesting read from medical devices perspective: Typically the regulatory developments in medicinal products precede and therefore can predict upcoming trends for medical devices, and the … Continue reading

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