Friday, 16 April 2021

IVDR Summary of Safety and Performance (SSP) Article 29

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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