Sabrina Dessources Thanks Donielle!

Good article! But haven't answered Sabrina's asking. I am also curious about this question: already compliance to EN ISO 13485, if ISO 13485 certificate required for the markets outside the EU.
Maybe need to ask the notified body why outside the EU.

Anthony Piotrkowski, RAC, CQA Unfortunately because national and regional organizations can tweak the standards when they adopt them there is no easy way that I'm aware of to know all the differences between regionally adopted and the original consensus standard. It will have to be managed on a case by case basis when seeking registration(s) in that area. Typically any changes to an international standard for adoption by a country are just to add any specific requirements that you would need to register the product anyway so if you meet the international standard and regional registration requirements you would meet the regionally adopted standard. Take ISO 14971 as an example. The normative text of the ISO and EN ISO are the same but the EN ISO has items specific to the European directives (i.e. MDD, IVDD and AIMDD) so if you conform with the international ISO 14971 and with the IVDD essential requirements you also conform with EN ISO 14971.
Sounds like a business opportunity to start a business publishing the key differences between regional and international standards.

Karen Boyd, ASQ CQA I would utilize / adhere to the stricter (EN / EU) standards, to ensure compliance with all regions in your market. Unless you have dedicated product / devices you will segregate for export, it's best to cover your bases.

Karen Boyd, ASQ CQA Aside from ISO, any med devices sold / present in the European market must comply with EU Medical Device Directives and ancillary requirements.

There is an excellent article on this subject on the Standards Forum. http://standardsforum.com/what-is-the-difference-between-an-iso-en-iso-and-bs-en-iso-standard/.

According to BSi (http://medicaldevices.bsigroup.com/en-GB/news-centre/enews/2012-enews/EU-Publishes-EN-ISO-13485-2012/), the only differences are in the foreword and annexes. However, the annexes are important for those who market in the European Community as they spell out the MDD, IVDD, and AIMD directives.

Sarah H. Stec, RAC It really does depend on where you're going to be selling your devices. You would have to make sure that, for example, even though you may have an ISO 13485 certificate, it's (a) the same version as what is required in the regulations (i.e. maybe not an EN ISO 13485:2012 certificate), and (b) your QMS still meets the regulatory requirements that the jurisdiction requires. ISO 13485 is the same throughout the world, but you have to see if, for example, CAN/CSA ISO 13485 is the same as ANSI/AAMI ISO 13485 is the same as EN ISO 13485 is the same as NBR ISO 13485, etc., with respect to your operations. You may not need to duplicate all the standards, but you would need to comply with the regulatory requirements. If the regulations require conformity to a country-specific version of the standard, you would need to make sure that you conform to the country-specific version.

You may need to check with Your management marketing plan and direction. As Regulation Requirements are vary country by country. ISO Standard is only addressing Standard and some Technical guide, therefore individual country may have their own regulation requirements which you will need to add on to your QMS in order to compliance the country requirements. In short your ISO QMS does not address all country regulations which you will need to research and find out the differences to add on to your QMS documentation and implementation. Hope it helps.

Karen Boyd, ASQ CQA Good decision, Sabrina. Best of luck!

Sabrina Dessources Thank you all for your input! I know regulations vary by country and we've already addressed that. I decided to only keep ordering the applicable BS EN ISO Standards since they have the same core text as the ISO standards and any additional information/requirement would be listed in their annexes.

Brian Matthews The technical content of the ISO and EN ISO text should be identical.

The additional Annex Zs in EN ISO documents are intended to show how the technical content helps show compliance with the applicable EU Directives.

An important additional source of information is the current list of Harmonised Standards (published in the Official Journal of the European Union from time to time). If a particular standard is not listed there then there is no presumption of compliance with relevant essential requirements.

There is at present a dispute with the Commission relating to the wording of Annex Zs - thus many newer standards have still to be listed under harmonised standards texts.

Lisa Olson Additionally, you can look at the introduction sections of the EN standards. They very frequently explain exactly what the similarities and differences are between the EN and ISO standards. Mostly, it is related to the approval date and some EN introductory language.

We compiled a list of all standards required for our device in an excel spreadsheet, which jurisdiction requires which standard and an equivalency assessment for each of them. This systematic approach ensures that all gaps are identified, the choice of standards purchased and used is justified (e.g. EN ISO only vs. other equivalent standards) and the review is documented and provided as evidence during audits/inspections. We still reference the country specific standards as required for certain documents and records; however, we will not purchase these country specific standards if the assessment proved equivalency with the standard of our choice.
If they are not equivalent then the answer is obvious.

If you comply with EN ISO, you are automatically in compliance with ISO standards. When registering product in US or Canada, in your application mention ISO equivalent of your EN ISO standard as they recognize only ISO standards. In your documentation you can mention EN ISO because that is what you adhere to, and can write in brackets (equivalent to ISO).

Headline: "Members shower Sabrina with valuable insight." Thanks, everyone, for making this group such a resource for so many users.

Annamaria Heldne Nagy Exactly, as far as I know ISO EN standards should be identical with the respective ISO standard. That (or if not, that) is usually the first sentence in the foreword.

The same goes for the country specific adaptations; with a BS EN ISO 13485 cerificate you are able to sell in Germany, you don't need a DIN EN ISO 13485 extension.