The new EU Medical Device Regulation and In-Vitro Diagnostics regulations (EU MDR/ IVDR) are now published and effective as of 2020. Industry now needs to prepare becoming full compliance in meeting the demanded requirements in order to sell product in the EU, then.
We conducted selected industry and expert interviews on the impact in countries and across product risk classes, as well as applied 3 dedicated questions in the recent LIMEDex Index survey to gauge the sentiment of Medtech Leaders. Now we are in the unique position to provide peer reviewed quantitative estimates and qualitative detailed answers to the below concerns:
- Who is affected by the new EU MDR/ IVDR?
- Which challenges affected companies most?
- What are the associated operational cost to reach compliance readiness?
- What resources and skill are needed?
- What mid-term staffing levels are needed?
- What system costs arise to major EU producing nations?
- Are non-industry stakeholders i.e. Governmental agencies or Notified bodies also affected?
- What tactical and strategic options are possible?
- Are there any alternative "out of the box" avenues for stakeholders?
- ... and more
If you are interested in a further deep-dive discussion on this subject, please feel free to contact us at your convenience:Yes, I would like to enter in a dialogue on how to scale up our Government Affair strategy potentials an Benchmark our EU MDR readiness, now - please contact us