"Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufacturer

NicoleinFlorida

Inactive Registered Visitor
#1
Hello the cove,

I have question about the description on CE/ISO Certificate.

We have ISO 13485 Certified Contract Manufacturer that provide sterile medical device for use. Our consultant noticed that the ISO/CE certificate fails to specify "Sterile". When I talked with the representative of Contract Manufacturer, the lady told me that the NB audited the ISO Certificate of the Sterilizer and also products's sterilization validation report. But she was unaware that the "sterile" is required on the certificate.

I am not very familiar with the NB certificate process. And after googled for a while, I haven't get any clue about the requirement of "Sterile" for class IIb product. Is this required for the certificate if the contract manufacturer provides the sterile device for us? And how is the auditing process for the sterile?

Really appreciate it.
 
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bjohnsonrli

Starting to get Involved
#2
Re: "Sterile" missing on the CE Certificate

Hi Nicole,

I am no expert in this matter, however what I have seen on our own contract sterilizer's ISO cert includes "sterilization services" in the scope. I would think that sterilization should be listed as one of their registered activities. Hope this helps.

Regards,

Bryan
 

Ronen E

Problem Solver
Staff member
Moderator
#3
Re: "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufactur

Hello the cove,

I have question about the description on CE/ISO Certificate.

We have ISO 13485 Certified Contract Manufacturer that provide sterile medical device for use. Our consultant noticed that the ISO/CE certificate fails to specify "Sterile". When I talked with the representative of Contract Manufacturer, the lady told me that the NB audited the ISO Certificate of the Sterilizer and also products's sterilization validation report. But she was unaware that the "sterile" is required on the certificate.

I am not very familiar with the NB certificate process. And after googled for a while, I haven't get any clue about the requirement of "Sterile" for class IIb product. Is this required for the certificate if the contract manufacturer provides the sterile device for us? And how is the auditing process for the sterile?

Really appreciate it.
Essentially when a manufacturer applies to be certified by a NB they include the product scope in the application. Once this is agreed with the NB, this is the scope the NB will audit and certify to. I guess that they didn't include the "sterile" in their application, for some reason (maybe inadvertently).

It sounds as if the NB did audit them as a sterile devices manufacturer, otherwise they wouldn't have audited the sterilisation validation etc. However, it's better to be safe than sorry, so I would ask your CM if they could apply with their NB for a change of scope based on the audit that already took place. If indeed it's a matter of oversight, the NB wouldn't have a problem fixing the certificate. However, if they have indeed only certified the non-sterile production it will require re-certification. In the latter case it'd actually be a good thing that you brought it up.

Cheers,
Ronen.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#4
Re: "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufactur

Is this required for the certificate if the contract manufacturer provides the sterile device for us? And how is the auditing process for the sterile?
If your organization really wants the contract manufacturer (CM) to only deliver sterile medical device products, this obviously should be stated in your purchasing documents with the supplier and, if the CM/Supplier only delivers sterile products, their ISO 13485 certificate should mention this key aspect.

Also, you can familiarize yourself with the NBOG’s Best Practice Guide document concerning the certificates issued by NB's. Download the document and search for the 11 instances of the word sterile in it.
 

NicoleinFlorida

Inactive Registered Visitor
#5
Re: "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufactur

Thank you for pointing out about the application scope. I will contact with the CM about this.

As part of our contract, we require our CM to have ISO certificate for the our products, which means Sterile is mandatory.
 

NicoleinFlorida

Inactive Registered Visitor
#6
Re: "Sterile" missing on the CE Certificate - ISO 13485 Certified Contract Manufactur

According to the contract, the CM will provide Sterile Medical Devices for us. Per supplier qualification, they must be ISO 13485 Certified for the manufacturing of our products.

Thank you for the document :)
 
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