The subject of your question is “ISO 13485 2016 vs EN ISO 13485:2016” however the text of your question concerns the differences between “ISO 13485:2016 vs EN ISO 13485:2012”. I’ll offer a generic answer for “ISO 13485 2012 vs EN ISO 13485:2012” and then expand it.
First, realize the ISO 13485:2003 is an international standard. Each country or region standards organization adopts the standard, renames it, and may object to certain parts. In the US, it is AAMI/ANSI ISO 13485:2003; in Canada, it is CAN/CSA 13485-03; and in the EU, it is EN ISO 13485:2012.
In addition, each country regulatory agencies “recognize” the various standards. In the US, FDA does not recognize either ISO 13485:2003 or AAMI/ANSI ISO 13485:2003. In Canada, Health Canada recognizes both ISO 13485:2003 and CAN/CSA 13485-03. In the EU, only EN ISO 13485:2012 is harmonized to the directives.
The only region that requires a specific version is Canada, where the regulations require CAN/CSA 13485-03 for most device classes. The EU expects EN ISO 13485:2012, grants special status when it is used, but does not require it. The US would not allow either the international version or the US version, since QSR is required. However, the US does not object to any of the 13485 versions as an add-on to the QMS.
You asked (sort of) if a company could legally market an IVD in Europe with ISO 13485:2003 as opposed to EN ISO 13485:2012. The answer is NO, because ISO 13485:2003 does not satisfy the requirements of any of the device directives (MDD, AIMD, or IVDD). EN ISO 13485:2012 enumerates the shortfalls. You need to determine your conformity assessment path and review the appropriate Z annex to learn the additional requirements.
The issues with ISO 13485:2016 and EN ISO 13485:2016 are murky.
ISO 13485:2003 is now obsolete and replaced by ISO 13485:2016.
The US version is AAMI/ANSI ISO 13485:2016, which the US FDA does not (and never will) recognize.
I’m not sure about Canada today, but there is a plan to end the current CMDCAS system in favor MDSAP certificates that will be synchronized with the transition to ISO 13485:2016 QMS certificates.
In the EU, the standards body, CEN, issued EN ISO 13485:2016, but it is not (yet) a harmonized standard.
Because the EN versions of both standards are more restrictive than the international versions, if you implement the EN versions you would be in compliance with the international versions.
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Dan O'Leary
Swanzey NH
United States
Original Message:
Sent: 03-14-2016 15:38
From: Ramanjot Bhatia
Subject: ISO 13485 2016 vs EN ISO 13485:2016
Hello Everyone,
I had a question regarding regarding the differences in ISO 13485:2016 vs EN ISO 13485:2012. I work for FDA Class I exempt IVD & Self Declared General CE IVD company. We are located in the United States and sell our products to a variety of different countries internationally.
My questions are:
1. Can we sell our IVD products to Europe with ISO 13485:2016 ( without the EN version)?
2. Can we sell our products to countries that require ISO 13485 with EN ISO 13485:2012? (For example, Canada, Japan, Australia)
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Ramanjot Bhatia
Regulatory Affairs Specialist
San Francisco Bay Area, California
United States
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