Module 15 2022

19/05/2022

Translations

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

31

Translation

Translations: • Always requires an English version – even if not marketed in English speaking country. • Requires an SSCP in each member state language where the device is sold. • One SSCP per language. • Notified Body validate in one language (usually English). • SSCP will state which language was used for validation. • Notified Body will not review translations of validated SSCP.

• QMS should contain procedures on ensuring accuracy of translation. • Notified Body will audit the translation procedure during QMS audits.

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

32

16