Module 15 2022

19/05/2022

Notified Body and Validation

Role of the Notified Body: • The draft SSCP is validated by the Notified Body. MDR submission • Class III and class IIb implantable devices, except sutures and staples etc – • SSCP is validated as part of technical documentation assessment for every device. • The SSCP (validated) will be uploaded by NB at time of uploading issued certificate. • Class IIa implantable devices and some IIb implantable devices such as sutures and staples etc (WET) • SSCP of one representative device per generic device group (IIb implant)/per category (IIa implant) is validated. • The SSCPs for some devices within the product family are not validated at application. • During certificate cycle the SSCP for all devices within the product family will be validated. • All SSCPs (validated and unvalidated) covered by the MDR certificate will be uploaded by NB at time of uploading issued certificate.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

27

Maintenance of the SSCPs

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

28

14