Significant change related to design and intended use

[Jason zhang]

MDCG 2020-3 notes: 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 therefore allowed during the transitional period. Acc. to section 3 the certificate should not be amended.

According to this sentence, non-significant change is only allowed before DOA(2021/5/26).

Can MDD complaint device make significant change after DOA and prior to 2024/5/26 ?

 

[twanmul]

Any device products certified under the relevant directive that continue to be manufactured utilising transitional arrangements as listed within Article 120 of Regulation 2017/745 or Article 110 of Regulation 2017/746 from the respective date of application cannot have any change to the design of that device.
This means, from the date of application, no changes can be made to the device design. If you want to make changes, then you will need conformity assessment as per the appropriate regulation.

 

[Jason zhang]

So,
1. MDCG 2020-3 only apply prior to each DOA of regulations?
2. in addition to design change, is any other change allowed after DOA, such as manufacturing process change, administrative change and so on？

 

[fialor]

The text of MDCG 2020-03 does indicate that the changes considered non-significant can be made. This will invariably be down to the interpretation by your NB. I would recommend you ensure you know the guidance document inside out so that you have a productive discussion with your NB when required.