Module 15 2022

19/05/2022

Translation

Timelines: • Manufacturer cannot place a device on the market until the SSCP, in the native language for that market, is uploaded in EUDAMED. • Once the master SSCP this is uploaded to EUDAMED by the Notified Body: • Translations are then conducted as and when the manufacturer wishes to place a device on a specific market. • Translations submitted to Notified Body. • Notified Body uploads translations within 15 days of receipt.

• If the master SSCP is non English, once it is uploaded to EUDAMED: • Manufacturer provides the English version within 90 days to the Notified Body. • Notified Body uploads translations within 15 days of receipt.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

33

Summary

● MDR introduces the new requirement for SSCPs. ● Aim to improve transparency and access to information. ● SSCP required for class III and implantable devices. ● All SSCPs have a Healthcare Professional Section. ● Only certain devices require a Patient Section. ● MDCG 2019-9, rev 1 provide guidance on SSCP content. ● SSCPs are publically available on EUDAMED. ● It is the manufacturer's responsibility to maintain an up to date SSCP.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

34

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