Is ISO 13485:2003 Certification neccessary to get the CE Mark?

[Hello - 2006]

My company is planning to go for ISO 13485 adequacy audit on February 2004. But according to the auditor from SGS, the authorisation for auditing in accordance with ISO 13485:2003 is not given yet. The actual time is not known. But my customer is going to export the products to EU mid of next year, thus we need to be certified for ISO 13485 in order to get CE mark. Thus, if we are in hurry for the certification, the auditor advised us to go for ISO 13485:1996, then update to the latest version once it released. In doing this, we need to spend more on the certification where our budget is not allowed.

Anybody got any idea of the exact time for the commencing of the ISO 13485:2003?

 

[howste]

I'm trying to find this out also. I contacted the RAB (in the USA) and they sent me an email back stating basically that they were "in the process" of getting things established but they had not approved any registrars yet. I've heard some rumblings that UKAS may be a little further ahead, but no real solid evidence. Who is the accrediting body for Maylaysia? Maybe you could try contacting them to see how close they are to getting some registrars approved...

 

[Kevin Mader]

I'm in the midst of an audit right now, BSI, and I posed the question. Our auditor says that BSI will be going through their registration process later this month. From there, they will work off any deviations to recieve the green light to issue certificates.

May 2004 sounds like a safe bet that you'll be able to register once and under budget, at least with BSI. SGS is a solid firm and the predominant registrar in Asia. My guess is that they'll be on a similar path as BSI as they have a host of clients to support. I'll post here if I get any further word.

Regards,

Kevin

 

[Cathy]

Our auditor is SGS as well and they have told me to expect their accreditation to be through by spring.

What you can do to ensure you don't change you plans is to carry on implementing ISO13485:2003 and get audited against ISO13485:1996 This will be must easier in the long run. I have put a checklist for implementing this on this forum somewhere but send me your email address and I will send it directly to you.

this will not cost you any more money. upgrade at the another audit when you are ready.

You don't need ISO13485 to get a CE mark. ISO13485 is a QUALITY SYSTEM for Medical devices. Grant it, it helps attain the goal of acheiving the CE Mark but this is a product certification. I would be concentrating more on putting the technical documentation and Essential requirements in place! Check the European directive 93/42/EEC MDD this will give you other routes to getting the CE mark.

 

[Kevin Mader]

Looks like good advice!!

 

[Cathy]

Thanks Kevin.........means something coming from you. I have taken a lot of advice from your posts!

 

[Al Rosen]

You don't need ISO13485 to get a CE mark. ISO13485 is a QUALITY SYSTEM for Medical devices. Grant it, it helps attain the goal of acheiving the CE Mark but this is a product certification. I would be concentrating more on putting the technical documentation and Essential requirements in place! Check the European directive 93/42/EEC MDD this will give you other routes to getting the CE mark.

Cathy:

That is not completely true. Depending upon the device and the annex of the MDD you may need a 3rd party audited Quality System to get a CE mark to market the device in the EU.

 

[Aaron Lupo]

You don't need ISO13485 to get a CE mark. ISO13485 is a QUALITY SYSTEM for Medical devices. Grant it, it helps attain the goal of acheiving the CE Mark but this is a product certification. I would be concentrating more on putting the technical documentation and Essential requirements in place! Check the European directive 93/42/EEC MDD this will give you other routes to getting the CE mark.

Cathy-

While agree with what you are saying about not needing ISO Certification to have your product CE marked, I have to say this. There are Notified Bodies out there that will "force you" to have ISO Certification before they will give you a CE mark. What happened to us was a very long and ugly issue and almost caused us to lose our largest customer. It is a long ugly story that involved TUVPS/MS, if you would like the details feel free to ask me.


AL-

You are 90% correct is stating that you will have to have a third party audit to attain a CE mark, however, depending on the class of the Medical Device you may be able to self CE Mark the product.

 

[Al Rosen]

ISO GUY:

Not to split hairs. I said, "Depending upon the device and the annex of the MDD you may need a 3rd party audited Quality System to get a CE mark to market the device in the EU."

Also, although you may self certify for a class I device, you still need to meet the requirements of EN 46000 or ISO 13485 before you can self certify, as that is part of what you are certifying. So, just to clarify you need a QMS (3rd party or not) and a Technical File before you can self certify.

 

[Cathy]

There are Notified Bodies out there that will "force you" to have ISO Certification before they will give you a CE mark. What happened to us was a very long and ugly issue and almost caused us to lose our largest customer. It is a long ugly story that involved TUVPS/MS, if you would like the details feel free to ask me.

I am very disappointed to here this. Notified bodies do not run the business and their opinions cannot be forced on you. I would like to talk to you more about this. We are probably so maybe a new thread?

One thing I make sure I do is keep well on top on the regulatory side so I can't be brain washed by my notified body - in saying that they are very good - but unfortunately you are not the first person I have spoken to about something like this.