EU Harmonized Standards - Withdrawals and Replacements

MiamiDM

Starting to get Involved
#1
If a standard under the most recent list of harmonised standards for the MDD (93/42/EEC), dated 17 Nov 2017, is withdrawn by ISO/other authorities, does its replacement automatically become the harmonised standard?

e.g., BS EN ISO 10993-11:2009 (ISO 10993-11:2006), was superseded by ISO 10993-11:2017 in Sept 2017.

Thank you
 
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Marcelo

Inactive Registered Visitor
#2
No, harmonization only applied to European standards, not ISO standards.

Even so, publication (or revision or withdrawing) of a standard by a SDO (standard development organization) is not related to harmonization (harmonization is performed under the EU Commission, under regulatory requirements).
 

MiamiDM

Starting to get Involved
#3
Thank you.

Sorry to labour this one.
So when an EU standard say EN ISO 10993-11:2009 that has been harmonised by the EU Commission is withdrawn, but a more up to date version is available, what standard do I need to comply with to support a CE submission for EU approval?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Thank you.

Sorry to labour this one.
So when an EU standard say EN ISO 10993-11:2009 that has been harmonised by the EU Commission is withdrawn, but a more up to date version is available, what standard do I need to comply with to support a CE submission for EU approval?
If you comply with the harmonized standard you will benefit the presumption of conformity to the extent listed in its Z Annexes, regardless of its status at ISO.
If you comply with a more current standard (not yet harmonized) you can claim in your ER checklist (and in your audit in general) that you kept with the state-of-the-art, and your NB might concur, but it's at their discretion (sometimes there are controversies when a new revision is published).
 

Marcelo

Inactive Registered Visitor
#5
So when an EU standard say EN ISO 10993-11:2009 that has been harmonised by the EU Commission is withdrawn, but a more up to date version is available, what standard do I need to comply with to support a CE submission for EU approval?
None, as standards are voluntary in the EU medical device regulatory scheme. If you want to get presumption of conformity, you need to use EN ISO 10993-11:2009 (which is the harmonized standard). You can use any other method, but in this case you do not gain presumption of conformity.
 

craiglab

Involved In Discussions
#8
Harmonized standards that are published in the official journal of the EU are the standards that when complied with give a presumption of conformity with the relevant parts of the essential requirements.
Refer to the list here: Medical devices - Internal Market, Industry, Entrepreneurship and SMEs - European Commission
If you want to apply a more recent standard then that's great (and I encourage it) but you still need to show compliance with the version in the OJEU.
 
#9
Thank you. So in the case that there is a new EN ISO that is not harmonized, should our standards list/tech file have both the older, harmonized standard and the newer standard after the gap analysis shows conformance? Is there a risk of only listing the newer standard?
 

craiglab

Involved In Discussions
#10
The way a notified body put it to me once was "it is perfectly fine to follow and reference the newer standard but also you need to follow and reference the one in the OJEU. Do not assume the newer standard will be adopted and appear there." Gapping is good and should be done. But if you do not list in your table (and ER checklist) the version shown in the OJEU then your NB will likely ask, and then you will need to show, and this just add time and complexity to the review of your technical file.
 
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