MDR Class I
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Report type: PMSR
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How submitted: Only upon request
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Update frequency: When necessary*
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Content: MDR Annex III/1.1
If you need help, contact us for a complimentary consultation at info@xybel.com
* A competent Authority or Notified Body may request your PMSE or PSUR at any time
MDR Class IIa
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Report type: PSUR
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How submitted: During Notified Body Conformity Assessment review
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Update frequency: At minimum every 2 years
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Content:
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Benefit/Risk determination
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Findings of PMCF (Post Market Clinical Follow-Up)
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Sales volume
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Estimated user population characteristics and usage frequency.
If you need help, contact us for a complimentary consultation at info@xybel.com
MDR Class IIb (non-implantable)
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Report type: PSUR
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How submitted: During Notified Body Conformity Assessment review
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Update frequency: At minimum every year
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Content:
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Benefit/Risk determination
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Findings of PMCF (Post Market Clinical Follow-Up)
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Sales volume
-
Estimated user population characteristics and usage frequency.
If you need help, contact us for a complimentary consultation at info@xybel.com
MDR Class IIb (implantable) and Class III (all)
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Report type: PSUR
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How submitted: Maybe via EUDAMED for Notified Body review
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Update frequency: At minimum every year
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Content:
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Benefit/Risk determination
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Findings of PMCF (Post Market Clinical Follow-Up)
-
Sales volume
-
Estimated user population characteristics and usage frequency.
If you need help, contact us for a complimentary consultation at info@xybel.com
IVDR Class A and Class B
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Report type: PMSR
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How submitted: Only upon request
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Update frequency: When necessary*
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Content: IVDR Annex III/1
If you need help, contact us for a complimentary consultation at info@xybel.com
* A competent Authority or Notified Body may request your PMSE or PSUR at any time
IVDR Class C
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Report type: PSUR
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How submitted: During Notified Body Conformity Assessment review
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Update frequency: At minimum every year
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Content:
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conclusions of the benefit-risk determination
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the main findings of the PMPF (Post Market Performance Follow-Up)
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the volume of sales of the device and
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an estimate of the size and other characteristics of the population using the device and, where practicable,
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the usage frequency of the device.
If you need help, contact us for a complimentary consultation at info@xybel.com
IVDR Class D
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Report type: PSUR
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How submitted: Maybe via EUDAMED for Notified Body review
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Update frequency: At minimum every year
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Content:
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conclusions of the benefit-risk determination
-
the main findings of the PMPF (Post Market Performance Follow-Up)
-
the volume of sales of the device and
-
an estimate of the size and other characteristics of the population using the device and, where practicable,
-
the usage frequency of the device.
If you need help, contact us for a complimentary consultation at info@xybel.com