MDSAP Audit Approach (MDSAP AU P0002) C5-T13: Control design changes (verify or validate and approve before implementation, assess new risks), notify regulators or the MAH where required, and assign new UDI-DIs for new versions or packages

What does C5-T13 require?

Design changes must be identified, verified or validated as appropriate, approved before implementation and assessed for new risks, which must be mitigated as far as practicable, with post-production feedback considered. Australia: the manufacturer needs procedures to notify its auditing organisation of substantial changes to the design process or product range (Sch 3 cl 1.5) and to notify the assessment body before implementing substantial changes to the design or intended performance of a Class III device or Class 4 IVD (cl 1.6(4)), and the TGA too if it holds a TGA conformity assessment certificate. Brazil: changes to registered or notified devices must be submitted to ANVISA promptly where required (Law 6360/76 Art 13). Canada: significant changes to Class III or IV devices need a licence amendment (CMDR 1, 34). Japan: the marketing authorization holder files new, change or notification applications, and Registered Manufacturing Sites must communicate modifications to the holder (MO169 Art 29). United States: a new 510(k) or PMA supplement where required, and a new device identifier whenever a change creates a new version or model, or a new package is created (21 CFR 830.50). Clauses: ISO 13485:2016 4.2.1, 4.2.3, 7.1, 7.3.9, 7.3.10, 8.2.1.