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How Companies are Gearing Up for Compliance with Europe’s
New Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)
1.
Has your registrar/notified body submitted the application to be qualified to review your product type?
Yes
No
Don’t know
2.
How much additional staff will your company have to hire to meet the requirements of MDR/IVDR?
0%
1% - 20%
21% - 40%
41% - 60%
Above 60%
3.
Do you plan to have consultants assist you with your compliance efforts?
Yes
No
4.
Do you believe that your registrar/notified body will be able to get your firm qualified in time for you to get your files reviewed?
Yes
No
5.
Do you believe that the European Commission will grant an extension to the implementation deadline, which currently is 3 years for MDR and 5 years for IVDR?
Yes
No
6.
Have you verified with your in-country representative in the non-EU countries in which you have provided registrations that the change in CE marking requests will not affect those countries’ registrations?
Yes
No
7.
Has your company discussed the requirements of MDR/IVDR with your European importers and distributors?
Yes
No
8.
How many legacy products will your company discontinue distributing in the EU because of MDR, IVDR?
None
0% - 5%
6% - 10%
Greater than 10%
9.
For what percentage of legacy products do you plan on setting up clinical trials?
0%
1% -10%
11% -20%
21% - 40%
Greater than 40%
Current Progress,
0 of 9 answered