Implementation deadline - non significant change acc. to MDCG 2020-3

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Daliane101

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When NB approves the non-significant change (name change on label and IFU), what is the timeline to implement that change? This is not stated in 2020-03.
 
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IVDRegs01

Registered
Worth checking that existing worldwide registrations won't be impacted by the change to the ISO 13485 certificate - Canada, for example, have a 30-day deadline from receipt of the certificate with the changed name to notification of Health Canada of the change. A thorough Regulatory Impact Assessment would help in this regard.
 
Orca1

Orca1

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Daliane101 said:
When NB approves the non-significant change (name change on label and IFU), what is the timeline to implement that change? This is not stated in 2020-03.
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The timeline to implement a non-significant change, such as a name change on the label and IFU, is not explicitly stated in MDCG 2020-3. However, it is important to note that if a change is not a significant change in design or intended purpose under MDR Article 120(3), the implementation of such a change is allowed during the transitional period, and the certificate should not be amended.
(Medical Device Coordination Group (MDCG), MDCG 2020-3, Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD, Notified bodies, Page 4, Paragraph 1)

In the context of US regulations, the labeler of a device must submit an update to the FDA no later than the date a device is first labeled with the changed information. If the information does not appear on the label of a device, the updated information must be submitted within 10 business days of the change.
(21 CFR 830.330(b), Times for submission of unique device identification information)
 
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