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

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

How much additional staff will your company have to hire to meet the requirements of MDR/IVDR?

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* 2. How much additional staff will your company have to hire to meet the requirements of MDR/IVDR?

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

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

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?

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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?

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?

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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?

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?

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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?

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

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

How many legacy products will your company discontinue distributing in the EU because of MDR, IVDR?

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* 8. How many legacy products will your company discontinue distributing in the EU because of MDR, IVDR?

For what percentage of legacy products do you plan on setting up clinical trials?

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* 9. For what percentage of legacy products do you plan on setting up clinical trials?

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