Module 15 2022

19/05/2022

SSCP: Obligation to Maintain Up to Date

CER/PMCF evaluation report/PSUR cycles: • These can impact on clinical data – review of SSCP to ensure it is up to date.

• Class III and IIb annual PSUR • Class IIa – at least 2 yearly PSUR. • PSURs submitted along with any updated SSCP to Notified Body. • 15 day period before uploading: NB either validates or defers validation.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

29

SSCP: Obligation to Maintain Up to Date

Renewal: • Class III and class IIb implantable devices, except sutures and staples etc – • Draft SSCP is submitted to the Notified Body along with renewal documentation. • Class IIa implantable devices and some IIb implantable devices such as sutures and staples etc (WET) • Confirm SSCP is in line with EUDAMED version (no re-assessment), or provide updated SSCP for validation.

• SSCPs uploaded at point of renewal.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

30

15