TÜV SÜD MDR Interpretation: Language requirements for safety und clinical performance?
November 17, 2019
What are the language and transparency requirements for the summary of safety and clinical performance (SSCP) for implantable and class III devices (other than custom-made or investigational devices)? The MDR requires for those devices a summary of safety and clinical performance (SSCP). The recent MDCG guidance document on SSCP clarified that medical device manufacturers are required to submit at least one language accepted by the notified body for validation.
(TÜV SÜD accepts English or German language.) This version shall be translated into the languages accepted in the member states where the device is envisaged to be sold. Even though the medical device manufacturer does not plan to place the device in an English-speaking country, English-language version of the SSCP shall be provided as well. The translation will not be validated by the notified body, but the notified body is required to upload the initial version and the translated SSCP documents to Eudamed to ensure transparency.