How Companies are Gearing Up for Compliance with Europe’s
New Medical Device Regulations (MDR) and In Vitro Diagnostic Regulations (IVDR)

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* 1. Has your registrar/notified body submitted the application to be qualified to review your product type?

Yes

No

Don’t know

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* 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%

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* 3. Do you plan to have consultants assist you with your compliance efforts?

Yes

No

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* 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

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* 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

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* 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

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* 7. Has your company discussed the requirements of MDR/IVDR with your European importers and distributors?

Yes

No

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* 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%

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* 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%