MedTech Europe publishes three position papers on building blocks of MDR and IVDR

Posted on 01.12.2017

On 21 November 2017 MedTech Europe published its policy papers on what it considers being the building blocks of the new in vitro medical devices (IVDs) and medical devices (MDs) regulations to ensure timely implementation and continuous availability of needed products within the foreseen timeframes.

Concretely, MedTech Europe calls 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. (find policy paper on Governance here)
  • Ensure the capacity and availability of Notified Bodies early in the transition periods (find policy paper on Notified Bodies here)
  • Ensure that all actors have a consistent interpretation and respect of the transition periods of the new regulations (find policy paper on transitions here)

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.