Tuttlingen – MedicalMountains GmbH and the Johner Institute want to know together where and how authorities or notified bodies may be exacerbating the current (regulatory) problems: According to industry feedback, the work currently consists of obtaining assessments from the authorities concerned.
The survey was launched at the end of April and was addressed to medical technology companies as well as notified bodies themselves: Are there demands that are viewed as unfounded? And what consequences does this have, for example in terms of costs or duration of approval? The feedback from the industry was clustered according to “addressees” in order to obtain assessments from those institutions that are considered to be the cause of the demands mentioned.
The initiators of the survey are still at this point. “In order to better understand the problems and be able to eliminate them, exchange with authorities, notified bodies or the MDCG is necessary,” reminds MedicalMountains managing director Julia Steckeler. Some points could be answered quickly, while others required further discussion. Accordingly, a final publication will still take some time. “There is definitely a willingness to engage in dialogue, and that is a valuable interim result,” says Julia Steckeler.
