Regulatory Open Forum

 View Only
  • 1.  MDCG 2020-3

    Posted 02-Jun-2023 08:39


    Nice meeting you all! 

    Here a questions regarding the MDCG 2020-3 guidance on significant changes:

    How should the "assess and accept" of the corrective action related to the significant change by local authorities be interpreted? Is it sufficient the local authorities received the FSCA (incorporating the corrective action) and accepted in general the corrective actions while the Notified Body conducts the review and approval of the related technical documents on everyone's behalf? Or should each local authority separately, next to the notified body, also conduct a full review and approval of the related technical documents?

    Thanks for any insights you can provide.

    Kind regards, Esther.

    Ester Daemen

  • 2.  RE: MDCG 2020-3

    Posted 04-Jun-2023 02:55

    Hello Ester,

    Welcome to the forums !  I am not sure there is a definitive answer to your question for multiple reasons.  While the MDCG was written as a guidance for understanding significant change of legacy devices, there is still disconnects between all of the parties involved.  The guidance was written by the MDCG group which may or may not have input from Competent Authorities or Notified Bodies - will profess that happens, but in reality, not so sure.  The entities involved such as Competent Authorities and Notified Bodies are all looking at the regulation from vastly different perspectives - again profess they say are all aligned, but in reality, not the case.  To answer your question a little, the Notified Bodies when auditing the quality system will ensure the regulation and your procedures are being followed.  The best approach you can take in that regard is ensure all of the documentation and objective evidence is clear, understandable, and complies with the requirements.  For the Competent Authority, if there is a FSCA involved, sometimes they will request the Technical Documentation to be "surrendered" so they can perform a review.  This means full information describing the device, including changes - significant or not - are fully described, rationales, testing performed, etc.  To fully answer the question would probably need to review a specific circumstance or situation because unfortunately it can vary significantly between the different entities depending on the situation.

    Richard Vincins ASQ-CQA, MTOPRA, RAC
    Vice President Global Regulatory Affairs