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

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

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

* 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?

* 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?

* 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?

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

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

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

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