Medtech industry on new regulations: Deliver early on building blocks to ensure timely implementation & continuous availability of products
Posted on 21.11.2017
21 November 2017 – MedTech Europe, the trade association representing the medical technology industry in Europe, is calling for swift action from national and EU authorities in ensuring the right foundations are in place to successfully implement the new in vitro medical devices regulation (IVDR) and the new medical devices regulation (MDR) within the foreseen timeframes.
In separate position papers published today, the trade association highlights three essential building blocks that authorities need to get right in order for the new regulations to succeed within the three-year (for medical devices) and five-year (for IVDs) transition periods.
Concretely, MedTech Europe is calling on the European Commission and Member States to:
- Invest additional resources needed to successfully implement the new regulations and clarify the new governance system under which guidance and secondary legislation will be developed. (see policy paper)
- Ensure the capacity and availability of notified bodies early in the transition periods. (see policy paper)
- Ensure that all actors have a consistent interpretation and respect for the transition periods of the new regulations. (see policy paper)
“As an example, the timely availability, the expertise and the sufficient capacity of notified bodies is absolutely critical for the medical technology industry” said Serge Bernasconi, CEO at MedTech Europe. “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”, he adds.
The industry association highlights that taking urgent actions on these three priorities as soon as possible will be vital in ensuring that patients, hospitals, laboratories and healthcare systems will have continued access to safe and innovative medical technologies.
For more information, please contact MedTech Europe’s Communications Senior Manager Jerick Parrone at [email protected]