ISO 13485 Certification and then CE Mark?

rwend07

Involved In Discussions
#1
Hey everyone,

We are looking to get ISO 13485 certification with the eventual goal of getting CE mark on some of our devices. Is it generally a good idea to get the certification done with the eventual notified body of choice? Does it matter if you get your ISO cert done with a different company than your NB?
 
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pkost

Trusted Information Resource
#2
I don't believe it is required to use the same organisation for ISO and CE, however I would strongly recommend it as there will be a consistent approach, it avoids unnecessary disagreements or contradictions and reduces your audit burden

If you do go for a different ISO certificating authority, you should use one that is appropriately accredited.
 

Mark Meer

Trusted Information Resource
#3
Yes, definitely try to find a certification body that can do both your ISO 13485 certification and act as EU Notified Body.

The reason being is that both ISO certification and CE certification require regular audits, with a fair amount of overlap. If you go through a single organisation, you can avoid the extra (much redundant) audits, and all the expenses, resources, and headaches extra audits entail.

MM.
 

rwend07

Involved In Discussions
#4
Yes, definitely try to find a certification body that can do both your ISO 13485 certification and act as EU Notified Body.

The reason being is that both ISO certification and CE certification require regular audits, with a fair amount of overlap. If you go through a single organisation, you can avoid the extra (much redundant) audits, and all the expenses, resources, and headaches extra audits entail.

MM.
So in general its a good idea to keep them the same so you don't get the redundancy of having a MDR related audit as well as an ISO 13485 audit. Makes sense, thanks.
 

paulag

Involved In Discussions
#5
Please consider that Notified Bodies are pretty stressed out with all the new EU MDR requirements...

Make sure find one pretty early in your process... one with the right accreditation for your device category, with enough ressources for a new ISO 13485 + CE marking
 

Mark Meer

Trusted Information Resource
#6
Please consider that Notified Bodies are pretty stressed out with all the new EU MDR requirements...

Make sure find one pretty early in your process... one with the right accreditation for your device category, with enough ressources for a new ISO 13485 + CE marking
Good advice to heed. Unfortunately there may be nothing you can do, except to factor in an extended schedule to CE marking, or else swallow the cost of having separate ISO certification body and Notified Body.

After being on a waiting list for months with our ISO CB for NB services, we finally gave up and transferred to another organization. After nearly a year, the ball is finally rolling for CE marking...

Bottom line: plan appropriately for time (and $$).

Best of luck!
MM.
 

rwend07

Involved In Discussions
#7
Good advice to heed. Unfortunately there may be nothing you can do, except to factor in an extended schedule to CE marking, or else swallow the cost of having separate ISO certification body and Notified Body.

After being on a waiting list for months with our ISO CB for NB services, we finally gave up and transferred to another organization. After nearly a year, the ball is finally rolling for CE marking...

Bottom line: plan appropriately for time (and $$).

Best of luck!
MM.

Man, that is rough. We have already had several companies come back and straight up tell us that they are filled up "until at least the New Year". It would be interesting to hear how many technologies are being held up and the potential human impact of the NB "fiasco".
 

Ronen E

Problem Solver
Staff member
Moderator
#8
Man, that is rough. We have already had several companies come back and straight up tell us that they are filled up "until at least the New Year". It would be interesting to hear how many technologies are being held up and the potential human impact of the NB "fiasco".
Better save the word fiasco to what's ahead with the advent of the MDR, 1.5-2 years down the track. I believe that what we see now is just the warm up.
 
#9
ISO 13485 certification is meant for company wide processes and CE Mark is for the product.

For CE Mark, it is critical to select a Notified Body (NB) that has product domain expertise, so that they understand your product and do not create any unreasonable roadblocks. Hence, my recommendation would be to first select an NB for CE and then check if they can also serve as the NB for ISO 13485. Selecting same notified body would help as you will work with consistent expectations.
 
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