Reporting of Design Changes to Notified Bodies (Annex IX, Article 4.10)

[Guy Aaronsohn]

Hi,
We're updating our change control process to address MDR requirements.
Annex IX, Section 4.10 stipulates that, "Changes to the approved device shall require approval from the notified body which issued the EU technical documentation assessment certificate where such changes could affect the safety and performance of the device or the conditions prescribed for use of the device."

I'm wondering is there an MDR specific guidance document on evaluating the effect of changes on safety and performance?
I'm familiar with the NBOG document on reporting of design changes and changes of the quality system under MDD/IVDD (NB-MED/2.5.2/Rec2) and have been told that it also applies to MDR. Is that the case?

Thanks!

 

[Billy Milly]

See also MDCG 2020-3.

 

[Guy Aaronsohn]

Thanks Billy Milly.

Isn't MDCG 2020-3 only applicable to legacy devices subject to the transitional provisions under Article 120?
Is it also applicable for devices with CE certificates issued under MDR?

I'm looking for guidance on determining which changes could affect the safety and performance of the device or the conditions prescribed for use of the device (MDR Annex IX, Article 4.10) and would therefore need to submitted in advance for NB assessment.

For MDD/IVDD we had the NBOG recommendations in NB-MED/2.5.2/Rec2, and I'm wondering if is there a similar document for MDR, or an indication that it can also be applied to MDR devices.

 

[EmiliaBedelia]

From my understanding, there isn't a specific guidance yet on MDR, but my NB (BSI) has advised to use the NBOG guidance under MDD as a guideline. In the absence of official guidance, I think notified bodies are basically just figuring out their own interpretation and guiding clients that way. So, your approach here will depend on who your notified body is and what they expect.

You should check to see if your NB has a change notification form or other documentation that they want you to submit. BSI has a checklist and notification form for changes that has a detailed checklist to complete as rationale for any changes. I'm required to notify them of nonsignificant changes anyway with a justification of why they are not significant so doing their checklist is generally sufficient.

 

[Ed Panek]

Our NB will not review substantial design changes under MDD any longer. We are also mid MDR review so....