Ann: Update - CE Marking Application, page-74

Is OSL going to win its view it needs no short or long term randomised trial for CE Mark.



https://bmjopen.bmj.com/content/9/2/e027041

Premarket evaluation of medical devices: a cross-sectional analysis of clinical studies submitted to a German ethics committee

From the consecutive sample of study applications between March 2010 and December 2013, we selected MD study applications requiring approval by an ethics committee and the competent federal authority. These included pre-market studies on devices that had not yet received a CE (Conformité Européenne) mark or had previously been CE marked for a different indication.


Conclusion A large proportion of MD studies in Germany apply a randomised controlled design, thus contradicting the industry argument that RCTs on MDs are commonly infeasible.