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Why are EU harmonized particular standards so old & out-of-date?

Mark Meer

Trusted Information Resource
#1
Just looking through the medical device harmonized standards list, in particular the 60601-2-x series particular standards, and am astounded by how out-of-date they are.

A whole bunch of them are 1990's versions, dating all the way back to 1993 (EN 60601-2-3)! I don't think there's a single one listed that isn't over a decade old!

All/most of these particular standards, so far as I'm aware, have much more recent IEC versions.

So a couple of questions:
  1. Can anyone in the know enlighten me as to why the harmonization is still to these ancient versions? Is it just the glacial pace of the harmonisation process? ...or is there some regulatory/principled reason why the more recent versions are not getting harmonised?
  2. What advice to manufacturers? Should we be testing to these outdated standards just because they are harmonised? ...or in most cases would an NB accept the argument that a more recent version is more reflective of the state of the art?
MM
 
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Mark Meer

Trusted Information Resource
#3
...maybe this thread addresses your questions and specifically this linked and this linked response?,
Thanks @planB! ...in summary, it seems that:
  • We can speculate that it might be due to interested parties disputing the Annex Z tables....but the harmonisation process is not very transparent, so who knows for certain.
  • The recommendation is to use both harmonised (old) version as well as the latest IEC version. ...which seems unnecessarily burdensome to manufacturers to me...but that's the state of things I guess... :confused:
 

planB

Super Moderator
#5
Mark,

there is some new information, taken from the most March 2021 EC newsletter:

Standardisation request in support of the new Regulations on medical devices

After the positive opinion of the Member States in the Committee on Standards on 12 March 2021, the European Commission is going to issue a standardisation request according to Regulation (EU) 1025/2012. Based on this, harmonised European standards under the medical devices Regulations are developed by the European standardisation organisations CEN and Cenelec. Once their references are published by the Commission in the Official Journal of the European Union, the voluntary use of those harmonised standards confer a presumption of conformity with the requirements of the Regulations they aim to cover.

To read about harmonised European standards, click here. To check the database of European standardisation mandates where the standardisation request will be published, click here.
Hope this helps,
 

Mark Meer

Trusted Information Resource
#6
Thanks for the links @planB!
...but I can't immediately spot what, precisely, has been "updated".
It seems as though the process is the same: Standards are issued by CEN/Cenelec, then published in the Journal.

Is the only new thing the search tool? If so, I can't seem to figure out how it works: For example, I type "60601-2-8" into the "number" field, but get no results. Does this mean that there is no current initiative to harmonise a newer version of this standard?
 

planB

Super Moderator
#7
Mark,

if you boil it down, then the only "new" thing is this: "After the positive opinion of the Member States in the Committee on Standards on 12 March 2021, the European Commission is going to issue a standardisation request." When you query for the MDR, you still get the "old" attached standardisation request from May 2020. Unfortunately, "60601-2-8" is not part of this request:
 

Attachments

Mark Meer

Trusted Information Resource
#8
It appears that none of the 60601 series particular standards (-2-x) are on the list...:confused:

As I say, there isn't a single one on the current (MDD) harmonised list that isn't more than a decade old (with many dating back to the 90's). Strange that there is no action being taken to update these...
 

Mark Meer

Trusted Information Resource
#10
Thanks @planB !

Am I reading this correctly, that the mandate is listing standards even before they are officially published as EN standards?
The standardisation request has been notified to CEN and CENELEC on 15 April for their acceptance in 1-month time....
For instance, has EN 60601-1:A2:2020 been published? It's listed in the mandate, but I can only seem to find the IEC version for purchase.

I'm not intimately familiar with the harmonization process, but it seems like this is quite a departure from previous process where it took forever to harmonize more recent versions...instead are they pre-emptively harmonizing from latest IEC standards??
 
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