Module 18 2021

07/02/2021

Current guidance (not yet replaced)

The Organisation for Professionals in Regulatory Affairs

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Article 117 of the MDR

• FOR THE DEVICE ASPECT OF A DDC: • General Safety and Performance (GSPR) checklist requirements apply • MDR Annex I

• Notified Body Assessment Report required • For inclusion within the MAA

• APPLIES TO ALL NEW SUBMISSIONS AFTER 26.05.2021

The Organisation for Professionals in Regulatory Affairs

22

11