Do I Need to Purchase the EN version?
Posted by Rob Packard on August 1,The author explains why it is not necessary to purchase the EN version, and provides an option to obtain the information you may need.
What?!
I thought the current version was ?
No, there was a minor correction in , but I haven&#;t heard about a version?
Great, now I have to buy another $ Standard that will tell us nothing new.
STOP!
If the above conversation sounds familiar, hopefully, this blog will help.
Question 1: What is the current version?
Answer 1: EN was revised to on July 6, The previous version was withdrawn. The ISO version is not changing&#;just the EN version.
Question 2: What&#;s new in ?
Answer 2: Only the three Annexes related to harmonization with the three directives (MDD, AIMDD, and IVDD) were updated. The content of the Standard itself has not changed.
Question 3: Do I need to buy this latest revision of the Standard &#; which really hasn&#;t changed since ?
Answer 3: No&#;unless, you still have the version. (just my personal opinion &#; not anyone else necessarily agrees)
And Here&#;s Why
Historically, Annex ZA was the annex at the back of a Standard that would explain how it is harmonized with the European Directives. However, in , Annex ZA was separated into ZA, ZB, and ZC. Each of these Annexes explained how the current version of ISO (then ISO ) differs from each of the three directives. In addition, there was a correction to Figure 1 (i.e., &#; arrow in the wrong location). Neville Clarke provided a good summary of these minor changes that occurred in The European Commission was concerned with some of the differences between the Standard and the Directives. Therefore, the Standard has been updated to clarify these differences.
There are seven technical deviations from the Standard that are required for compliance with the European Directives. Marcelo Antunes is an expert on Standards, and he accurately describes these deviations as &#;weird&#; in a discussion thread on Elsmar Cove&#;s Forum. The deviation that seems to have caught the most attention is the requirement to reduce ALL risk to &#;as low as possible&#; (ALAP) rather than to a level that to &#;as low as reasonably practicable&#; (ALARP concept). The &#;ALAP&#; acronym was a joke, but it wouldn&#;t be the first time that something like this stuck (i.e., &#; SWAG).
EN Version: An Alternative Approach
If you sleep with a label maker under your pillow, you should buy the new BS EN version, so you can ensure that you are staying in compliance with each of these seven deviations and that you have considered the implications fully in your procedure for Risk Management. However, if you are a practical person that prefers not to upset the entire development team, I recommend a different approach.
1. Download a copy of the relevant Directive from the Europa Website
2. Using Adobe, search the entire Directive for the word &#;risk&#;:
AIMDD = 24 times
MDD = 55 times
IVDD = 34 times
3. Systematically review where the word &#;risk&#; is used to determine if you need to make adjustments for your CE Marked products. If you already have a CE Mark, there should be no changes required to your risk management documents. Your procedures might need clarification to observe the requirements of the Directive when there is a difference between the Standard and the Directive.
Last Question: What is your Notified Body auditor going to do?
Final Answer: I&#;m not sure, because every auditor is a little different in their approach. However, as an instructor, I would teach an auditor to ask open-ended questions, such as: &#;How did you determine if there is an impact upon your procedures and design documentation with regard to the updated Standard?&#; (i.e., &#; impact analysis). If the company provides an impact analysis and explains why the existing risk documentation and procedure should not change, I believe this meets the requirements for &#;equivalency with the State of the Art.&#;
Honestly, I haven&#;t seen one single company that was % in compliance with the &#;letter&#; of the Directives or the Standard. Sometimes, rational thought must overcome political compromises and irrational behaviors.
On the other hand, it&#;s always possible that these seven deviations, and the information on corrective action, will fundamentally change the way your company approaches risk management (I just dare you to bring it up at your next management review).
If you would like a second opinion, the Document Center&#;s Standard Forumsays, &#;As you can see, this material is essential to conformance with the EN requirements and will make the purchase of the EN edition (BS EN ISO is the official English language edition) mandatory for medical device manufacturers certifying to the standard for sales in Europe.&#; FYI&#;Document Center&#;s Standard Forum sells Standards. You can buy this one from them for $
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