This document provides information on transitional provisions for products covered by Annex XVI of the MDR without an intended medical purpose. The information in this Q&A document is general and not intended to address the specific circumstances of any particular case.
Currently, 13 questions are addressed in this document. If needed, the document will be updated to address additional questions.
Here is the list of the questions. If you would like to know the answers, please see the reference.
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1. |
When are the CS applicable to Annex XVI products? |
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2. |
When is the MDR applicable to Annex XVI products? |
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3. |
What are transitional provisions foreseen for Annex XVI products? |
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4. |
What is the transitional period set out in the CS for products for which a NB is involved in the conformity assessment and the manufacturer decides to carry out a clinical investigation? |
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5. |
What is the transitional period set out in the CS for products for which a NB is involved in the conformity assessment and the manufacturer does not intend to perform a clinical investigation? |
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6. |
What is the transitional period set out in the MDR for Annex XVI products covered by an MDD certificate? |
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7. |
What is the transitional period set out in the CS for Annex XVI products covered by an MDD certificate? |
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8. |
What transitional periods set out in the CS for Annex XVI products covered by an MDD certificate were applicable before 22 June 2023? |
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9. |
What is the transitional period for products incorporating a medicinal product? |
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10. |
What are the transitional provisions for a dual-purpose device? |
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11. |
How can the manufacturers demonstrate that their product benefits from the transitional period? |
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12. |
Is there a deadline to make available products placed on market during the transitional period? |
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13. |
Can NBs issue certificates for Annex XVI products under the MDR during the transitional period?
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Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR