MDR Class I

 
  • Report type: PMSR

  • How submitted: Only upon request

  • Update frequency: When necessary*

  • 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

  • Report type: PSUR

  • How submitted: During Notified Body Conformity Assessment review

  • Update frequency: At minimum every 2 years

  • Content:

    • MDR Annex III/1.1

    • ​​Benefit/Risk determination

    • 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

 

MDR Class IIb (non-implantable)

  • Report type: PSUR

  • How submitted: During Notified Body Conformity Assessment review

  • Update frequency: At minimum every year

  • Content:

    • MDR Annex III/1.1

    • ​​Benefit/Risk determination

    • 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

 

 

 

 

 

 

 

MDR Class IIb (implantable) and Class III (all)

  • Report type: PSUR

  • How submitted: Maybe via EUDAMED for Notified Body review

  • Update frequency: At minimum every year

  • Content:

    • MDR Annex III/1.1

    • ​​Benefit/Risk determination

    • 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

  • Report type: PMSR

  • How submitted: Only upon request

  • Update frequency: When necessary*

  • 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

  • Report type: PSUR

  • How submitted: During Notified Body Conformity Assessment review

  • Update frequency: At minimum every year

  • Content:

    • IVDR Annex III/1, and 

    • 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

 

 

IVDR Class D

  • Report type: PSUR

  • How submitted: Maybe via EUDAMED for Notified Body review

  • Update frequency: At minimum every year

  • Content:

    • IVDR Annex III/1, and 

    • 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