Significant subcontractor update, still under MDD Certification, possible?

#1
Hi, we currently have a class III device registered under the MDD with BSI (so we have Full Quality Assurance System and Design-Examination Certificate). We would like to add a new significant subcontractor that will simply act as backup for one of the operation. However, I wonder if this would fall under article 120 of MDR and require us to file under MDR, as a significant change.
I have two questions:
  • Will this be considered a significant change and require us to undergo MDR filing?
  • How do we correctly define a significant subcontractor?
Thank you
 
Last edited:
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mboynton

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#2
Dear Lucius,

The MDCG guidance 2020-3 says the following about this type of change. Do you know if your notified body has commented on their approach to changes other than significant design changes?

Furthermore, all changes not having an impact on the design or the intended purpose of the device can be regarded as not significant in the meaning of MDR Article 120(3). This is the case for example of relocation or addition of new manufacturing sites, including when it affects subcontractors or suppliers, or of certain changes of the quality management system, provided that the conditions for which the conformity assessment certification was granted are maintained. Nevertheless, such changes continue to be subject to the agreed notification procedure identified in the first paragraph of the current section.

-https://ec.europa.eu/health/sites/default/files/md_sector/docs/md_mdcg_guidance_significant_changes_annexes_en.pdf

If the new supplier is a back-up to a subcontractor currently identified on your MDD certificate as a critical supplier/subcontractor, then I would believe that the new supplier also meets the definition of critical subcontractor, and that you are correct to seek Notified Body review in some form.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#3
Typically changes NOT INVOLVING the device directly (Design, claims) are non-significant per Art 120 of MDR but as this is the early application of this law an outreach to your NB is in order as changes to the QMS are also to be discussed.
 
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