Subcontractors Providing Services Under MDD or MDR need ISO 13485 from EU Notified Body?

K

kmottet

Registered
#1
#1
We are the legal manufacturer of a Class IIa medical device with a CE Mark under MDD. My notified body account representative just told me that subcontractors providing services under MDD or MDR have to have an ISO 13485 Certificate from a Notified Body listed on Nando. One of subcontractors is certified by an accredited firm (Intertek Testing Services NA Ltd) but because this firm is not listed on NANDO it is not acceptable? My understanding is that subcontractors should have an ISO 13485 certificate and if critical, could be subject to unnannounced audits. Has anyone else run into this issue before? Am I missing something? Is this actually a requirement?
 
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cfcruz

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Never ran into that issue. I believe their rationale is because there are other requirements concerning the QMS that the MDR has. And an accredited firm is just checking the ISO 13485 requirements and not the other ones. But having those other requirements set in a quality agreement and if needed your own audits to ensure they are covered shouldn't it suffice? Interested in having other people's opinions on this.
 
Y

yodon

Leader
Super Moderator
#3
#3
Compliance to a standard is NEVER a requirement. Always the best path, but they can't make it a requirement.

If the subs are certified then that helps; however, it must be through an accredited body. Certification from a non-accredited body is held in no regard when it comes to your NB assessing you.
 
Ronen E

Ronen E

Problem Solver
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#4
#4
kmottet said:
We are the legal manufacturer of a Class IIa medical device with a CE Mark under MDD. My notified body account representative just told me that subcontractors providing services under MDD or MDR have to have an ISO 13485 Certificate from a Notified Body listed on Nando. One of subcontractors is certified by an accredited firm (Intertek Testing Services NA Ltd) but because this firm is not listed on NANDO it is not acceptable? My understanding is that subcontractors should have an ISO 13485 certificate and if critical, could be subject to unnannounced audits. Has anyone else run into this issue before? Am I missing something? Is this actually a requirement?
Click to expand...
Regulatory creep!

Neither the MDD nor the MDR require ISO 13485 certification, let alone from a NB (in or outside NANDO)! The wording and intent are much more subtle than that, when it comes to suppliers / subcontractors. The important bit is to understand what actual requirements apply, and meet them - no more and no less.

The "Critical" terminology is as clear as mud, so don't go there unless you have to.

I've already seen NBs behaving like bullies, under MDD and now under MDR - they simply have so much power (I'd like to think "unintended power") in the current settings that they are free to enforce whatever comes to their mind and manufacturers often have no practical option but to submit to any whim.
 
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