What is the scope of EN ISO 13485 and ISO 13485 ?


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I am trying to understand the difference between using EN ISO 13485:2012 versus ISO 13485.

Is it that the EN version is an absolute requirement and all companies needing to have the medical device QMS in Europe ?

Could ISO 13485 be adopted by companies in Europe ?

Could US companies get certified to EN ISO 13485 ?


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ISO 13485 is the internacional standard, EN ISO 13485 is the "regional" European standard.

Normally, regulatory requirements have to use the national or regional stander, not the international one.

Standards are usually voluntary, their use may be compulsory because regulations require them.

In Europe, medical device regulations (directives)have quality system requirements (define in the CE Marking "routes"). Those are mandatory. One (voluntary) way to comply with these requirements is to use a harmonized standard. For the quality system requirements of the directives is EN ISO 13485. If you use it, you gain what is called "presumption of conformity" with the related requirements. So it?s usually easier to use the voluntary harmonized standard.

Please note that there?s no requirement for "certification" in the case of the European Directives and Harmonized standards (but certification is also one way to show that you comply with the standard, anyway).

Anyway, yes, a company in the US can get certified by EN ISO 13485.

Guillaume Prom

Note that requirements are the same in EN ISO and ISO versions.

But you will find informative annex (ZA, ZB and ZC) in EN ISO 13485 that show relationship between 13485 and the essential requirements of EU directive.
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