Europe ’ s medtech alliance seeks prompt action on new med device rules

European medtech industry group MedTech Europe today said it is seeking “swift action” from national and European Union authorities after the implementation of new regulations, saying that additional resources need to be invested to make sure the regulations are successful.
The medtech group published three separate position papers on the matter, calling attention to new in vitro medical device regulation and medical device regulations and what steps it believes need to be taken to make the regulations successful.
In its first paper, the group suggests that additional resources will be needed to help implement the regulations and to “clarify the new governance system” which will be used to develop secondary legislation.
The second and third papers cover the steps it sees as necessary to ensure the capacity and availability of notified bodies during transition periods and to ensure that involved parties have consistent interpretations and respect for transition periods of the new regulations.
“As an example, the timely availability, the expertise and the sufficient capacity of notified bodies is absolutely critical for the medical technology industry. We are stressing to the European Commission and Member States that they need to put the necessary resources to successfully complete the many joint assessments on-time,” MedTech Europe CEO Serge Bernasconi said in a press release.
Last December, two major European medtech industry groups, the E...

Source: Mass Device - November 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance MedTech Europe Source Type: news