Understanding when design changes require notification to regulatory bodies (FDA, EU Notified Bodies) and test labs (NRTL/CB) is critical for compliance. Early decisions during design can prevent costly re-submissions later.
FDA
510(k), PMA Supp
Test Labs
UL, TÜV, CSA
EU MDR
Notified Body
"Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation."
When your product has third-party safety certifications (UL, TÜV, CSA, etc.), many changes require notification even if no FDA submission is needed.
*Check your specific certification for requirements
Under EU MDR, "significant changes" to certified devices require Notified Body assessment before implementation. The MDCG 2020-3 guidance provides criteria for determining significance.
Important: For legacy devices transitioning under MDR Article 120, you must notify your NB of all significant changes. Failure to do so can result in loss of market authorization.
Determine when to notify test labs and regulatory bodies about design changes
Select the type of design change you are evaluating:
Important Disclaimer
This tool provides general guidance only. Actual notification requirements depend on your specific device, classification, certifications, and the complete risk analysis. Always consult with your regulatory affairs team, quality team, and certification bodies before implementing design changes. Requirements vary by certification body and regulatory authority.