Applicable for implantable devices and class III devices.
SSCP is written in a way that is clear to the intended user and patient.
SSCP is validated by notified body and after its validation, the notified body shall upload the summary to EUDAMED. Manufacturer shall mention the SSCP EUDAMED link in label or instructions for use.
SSCP content is given below,
Click below link to know more about IVDR SSP:https://meddev-info.blogspot.com/2021/04/ivdr-summary-of-safety-performance-ssp.html
Source:
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation
(EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council
Directives 90/385/EEC and 93/42/EEC
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