Applicable for class C and D devices.
SSP
is written in a way that is clear to the intended user
and patient.
SSP is
validated by notified body and after its validation, the notified body shall
upload the summary to Eudamed. Manufacturer shall mention the SSP Eudamed
link in label or instructions for use.
SSP content is given
below,
Click below link to know more about MDR SSCP:https://meddev-info.blogspot.com/2021/02/article-32-summary-of-safety-and.html
Source: REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
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