ISO 13485 vs. EN ISO 13485

We are General IVD medical device company following EU Directive 98/79/EC on In-Vitro Diagnostic Devices.

Out notified body is trying to get us EN ISO 13485 certificate, which I am little skeptical about.

I think we need ISO 13485:2016 not EN version since we sell all over the world not only in Europe. Also, our product are General IVD-Self Certified CE mark not 4 digit CE marked from Notified Body.

Can someone please clarify this for me and let me know if we need ISO 13485 or EN ISO 13485? I know there is only one difference in Annex ZC with EN version but I don't want to get a wrong certificate for the company

Really appreciate your help.

 

With respect to ISO 13485:2016, there is no difference in the main text between EN ISO 13485 and ISO 13485. The only difference is the addition of the Z annexes.

Pads38 noted that all the Z-Annexes (the only difference between the EN and ISO versions) can be previewed here:
https://webshop.ds.dk/Files/Files/Products/M284881_attachPV.pdf

So, if you have ISO 13485, and can preview the Z-annexes (at link above, or through iso/bsi, etc. webstores), you don't need to purchase the EN version.

That being said, when it come time for CE certification, you will have to comply with MDD (in your case 98/79/EC), in which case the Z-annexes will be handy...

 

Thanks Mark. We have only 9001 and are in process of getting our 13485 certificate. The question is more for what's the right certificate than what standard should I purchase? I apologize if I confused you earlier.

 

The answer is: it doesn't matter for this standard. You can either:
1. Purchase the EN ISO 13485 version (with Z-annexes included); or
2. Purchase the ISO 13485 version, and supplement with the free preview of the Z-annexes from the webstores (see link in previous post).

Either will give you the same content. (2) might be cheaper, but as was pointed out in this thread, you can also get a single-license copy of the EN version from Estonian Standards for only 20 Euros!

When you start to shop around for a Certification Body (CB), they will ask you about your devices and where your intended markets are, and tack-on any "extras" accordingly. For example, if you intend to market in Canada, they'll tack on CMDCAS requirements (to meet Canadian medical device regulations requirements).

I'd say that the main decision for you is likely not EN versus ISO, but rather 2003 version versus 2016 version. The new version of ISO 13485 (2016) has just been released, and there is a 3-year transition period, so how you want to proceed at this point is up to you:
- If time and resources are limited, perhaps consider certifying to ISO 13485:2003 (the previous version), as this version is not significantly different from ISO 9001.
- Ultimately you'll eventually want to certify to the latest 13485 version (2016), which has diverged from ISO 9001 - so this route will likely entail more work.

NOTE: regardless of which standard you purchase, there's always an ISO 9001 comparison table, that will help you identify the relationship/gaps between ISO 9001 clauses and ISO 13485 clauses.

 

Versions of 13485 (as at March 2016)

ISO 13485:2003 - current international standard

EN ISO 13485:2012 - current European standard. Note the text is identical, but the Z annexes are added.

EN ISO 13485:2016 - just released new international and European standard, 3 year transition period.

Notified Bodies are entities that audit a manufacturer against the requirements of the European Medical Device Directives - they can only ever consider EN standards.

They will not be 'ready' to audit against the 2016 standard for, probably, a year.