Can the CE Mark Cert be used as Proof of Sterilization Conformity?

[Mor628]

Hi guys,

This is in relation to sterilization of medical devices. We have some manufacturers who outsource the sterilization process, and therefore provide us with a certificate from an accredited certification institution, which supports that the sterilization company is qualified and adheres to the required sterilization standard. This is great!

However, there are a few larger manufacturers who do in-house/internal sterilization. These guys have a sterilization plant/site within the factory and need not have to outsource the process.

Unfortunately, there isn't a certificate produced following this, making it difficult for us to sell the product when customers require sterilization certificates to validate the sterilization process.

How do I go about resolving this? At present, I am going to provide the customer with the CE cert Annex 5 (Directive 93/42/EEC), and also declarations of conformity from the manufacturer to the required sterilization standards.

Any advice ?

 

[Ronen E]

Re: Can the CE Cert used as proof of sterilization conformity?

Hi guys,

This is in relation to sterilization of medical devices. We have some manufacturers who outsource the sterilization process, and therefore provide us with a certificate from an accredited certification institution, which supports that the sterilization company is qualified and adheres to the required sterilization standard. This is great!

However, there are a few larger manufacturers who do in-house/internal sterilization. These guys have a sterilization plant/site within the factory and need not have to outsource the process.

Unfortunately, there isn't a certificate produced following this, making it difficult for us to sell the product when customers require sterilization certificates to validate the sterilization process.

How do I go about resolving this? At present, I am going to provide the customer with the CE cert Annex 5 (Directive 93/42/EEC), and also declarations of conformity from the manufacturer to the required sterilization standards.

Any advice ?

Hi Mor,

Does the scope on your supplier's Annex V EC certificate explicitly state "sterilization"? If so, I think what you provide might be sufficient, though I would prefer a sterilization CoC for each sterilised lot rather than a blanket CoC for general compliance with the sterilization standard.

There should be evidence that the sterilization process is validated and monitored on an ongoing basis, according to acceptable standards.

Cheers,
Ronen.

 

[Mor628]

Re: Can the CE Cert used as proof of sterilization conformity?

Hey Ronen,

The EC Cert says “Aspects of manufacture concerned with securing and maintaining sterile conditions” followed by a list a products.

The only other evidence, is the sterilization validation report which is also done by the factory. A 70+ page document, without any certificates attached.

Does a CoC trump a DoC?

 

[shimonv]

Re: Can the CE Cert used as proof of sterilization conformity?

Hi Mor628,
I wouldn't provide the customer with sterilization validation report because they are not in a position to assess its content.
CoC is specific to a lot whereas DoC is a general statement of compliance with the regulation.

Perhaps you can beef-up the CoC to include the LOT sterilization results.
With the CE certificate and DoC (supplied once) and CoC (per LOT) they should be content.

Shimon

 

[Ronen E]

Re: Can the CE Cert used as proof of sterilization conformity?

The EC Cert says “Aspects of manufacture concerned with securing and maintaining sterile conditions” followed by a list a products.

That's not the best, but I guess you'll have to make the best out of it. It would have been much better if the scope said "sterilization", plain and simple.

 

[Mor628]

Re: Can the CE Cert used as proof of sterilization conformity?

Well, the documentation is needed for a tender application, so we are yet to sell them any products. But I suppose we could suggest the inclusion of the CoC with the shipped goods.

The only way would be to ask the manufacturer to include sterilization during their re-certification?

 

[somashekar]

Re: Can the CE Cert used as proof of sterilization conformity?

Hey Ronen,

The EC Cert says “Aspects of manufacture concerned with securing and maintaining sterile conditions” followed by a list a products.

The only other evidence, is the sterilization validation report which is also done by the factory. A 70+ page document, without any certificates attached.

Does a CoC trump a DoC?

This is clearly indicating that STERILIZATION is not in the scope of the CE. It seems to be the very reason why a certificate is not produced.
A sterilization CofC with batch information that is dated and signed can only stand to substantiate ...

 

[Mor628]

Re: Can the CE Cert used as proof of sterilization conformity?

How can I attempt to resolve this? Should I suggest to the factory to include "sterilization" in their certificate?

Any other ideas?