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MedTech Europe seeks swift action on new medical device rules

MDBR Staff Writer Published 22 November 2017

European medtech industry group MedTech Europe is seeking swift action from national and EU authorities on the new in vitro medical devices regulation (IVDR) and the new medical devices regulation (MDR).

The trade association wants the authorities to make sure that the right foundations are in place to implement the new IVDR and the MDR within the foreseen timeframes

MedTech Europe has announced three separate position papers for authorities to successfully implement new regulations within the three-year (for medical devices) and five-year (for IVDs) transition periods.

MedTech Europe is seeking support from European Commission and member states to invest additional resources required to implement the new regulations and clarify the new governance system under which guidance and secondary legislation will be developed.

The organization is also calling the authorities to ensure the capacity and availability of notified bodies early in the transition periods.

It is also expecting a consistent interpretation and respect for the transition periods of the new regulations.

MedTech Europe CEO Serge Bernasconi said:  “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 is a trade association, which represents the medical technology industry in Europe.


Image: MedTech Europe is calling for swift action from national and EU authorities to implement new regulations. Photo: courtesy of arztsamui / FreeDigitalPhotos.net.