Tag Archives: ISO 14155

Clinical evidence under the EU Medical Device Regulation: More firework on the way.

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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INVESTIGATOR CLINICAL STUDIES: FOUR KEY THINGS TO DO

Last week some-one asked me what it is that industry can and can not do in investigator initiated trials (IITs). The challenge in answering this question goes back to the question who the sponsor – and therefore the one being … Continue reading

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FOUR (NOT) TO DO’S TO PREVENT PAPER WITHDRAWAL

The vote regarding the proposed Medical Device Regulation is once more postponed, so we will need some more patience before knowing where we are heading in Europe with the Medical Device Directive. One thing, however, speaks clearly from the proposal … Continue reading

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