"The EU Medtech eco-system is vastly exposed to possible shortcomings in reaching the governmental affairs readiness for the EU MDR regulation by 2020"
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 the subject of IMPACT of the EU Regulation on my business or cluster
, please feel free to contact us at your convenience
Yes, I would like to learn more on strategic and tactical options in best addressing our EU MDR Gap Analysis and readiness program - please contact us