ISO 14971:2019 & Europe MDR Risk Management Process Flow

Trying to understand the “state of the art” in medical device risk management?
This diagram attempts to distinguish between ISO and European requirements.

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ISO IEC EN Standards Hacks, Tips, Tricks

Subtitle: Buying standards from the Estonian Centre for Standardisation (EVS)

EVS is the national standards body in Estonia. Since Estonia is a member of the European Union they will publish ISO / IEC and CEN / CENELEC standards with the “EVS-” prefix added to the front of the designation See examples below.
Example A – ISO Standards
(the standard identification number 12345 and the Euro amounts are fictitious)
1. ISO publishes ISO 12345.
2. EVS offers this for sale as a “pure” ISO version for 150 Euros.
3. The European general standards body CEN publishes EN ISO 12345 (but CEN does not sell standards). The “pure” ISO version is inside the EN ISO version.
Note: In addition, for medical device standards the EN version typically includes “Informative” Z Annexes that map the requirements of the standard to the “Essential Requirements” in the European medical device Directives. In the future, the Z Annexes will likely map to the European Medical Device Regulation (MDR).
4. EVS publishes EVS-EN ISO 12345 and offers it for sale for 15 Euros.
Example B – IEC Standards
(the standard identification 54321 and the Euro amounts are fictitious)
1. IEC publishes IEC 54321.
2. EVS offers this for sale as a “pure” IEC version for 200 Euros.
3. The European electrotechnical standards body CENELEC publishes EN 12345 (but CENELEC does not sell standards).
Note: Not sure why, but when CENELEC publishes IEC standards as EN versions they remove the IEC designation entirely.
4. EVS publishes EVS-EN 12345 and offers it for sale for 20 Euros.
Here are the steps for purchasing PDF standards online from Estonia.
1. Create an account here.
2. Shop for and buy standards in “English” language from the EVS E-Shop (credit cards accepted).  E-Shop User Guide
Tips & Illustrations
– Reminders: CEN and CENELEC do not sell standards. They publish EN standards in English, French, German and provide them to the 33 (or so) European national standards bodies who publish them as XXX-EN versions, where XXX is the standards body prefix (examples: AFNOR, BSI, DIN, EVS, IS, SIS).
– In my searches for the least expensive standards available from European standards bodies, EVS has proven to be the “low-price-leader”. Some standards bodies do not appear to discount EN versions at all, unless you join as a paid member.
– It is always best/cheapest to buy the EN versions of standards instead of the “pure” ISO or IEC versions, especially from EVS. Reason: Cost is usually about 15% of the price, and you also get European Informative Z Annexes in addition to the “pure” ISO/IEC standard.
EVS EN v ISO Price Comparison.png
– The limitation and secret behind the low pricing is that the PDF file will only be able to be opened on a single computer, and you will only be able to print it twice, as explained in detail here:  Single-use licensing information
– There is a time delay between the publishing of a new/revised ISO/IEC standard and the publishing of the corresponding EVS-EN version. I usually wait for the EVS version and often email EVS to ask when it will be available. In some cases, the time delay leads to the YYYY “Year” for the EVS-EN version being one (1) year later than the ISO/IEC version. This is not a concern since the YYYY version of the ISO/IEC version is still disclosed (parenthetically) in the title of the standard.  Example:
EVS EN ISO 10993-11 2018 equals ISO 10993-11 2017.png
– When you look at EVS standards, you can disregard the first 2 pages. This same principle applies to standards published by all European national standards bodies. Look at this example to see what I mean:
– This screenshot shows the correspondence between an EVS-EN version and the ISO version of 13485:
EVS 13485.png
Happy standards shopping!

Sam’s List of FDA Registered Contract Manufacturers & Sterilizers in SF Bay Area

 Think global, buy local…and local for me is the San Francisco, California USA area.

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