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Appendix Z in Harmonised Standards?

Cybel

Starting to get Involved
#1
Hi
I’m working on the table of General Safety and Performance Requirements of MDR.
During a training activity on MDR, the teacher has explained that harmonised standards contain an appendix (maybe Appendix Z?), which defines which directives and ESRs the standard meets. Actually, I’ve found this information in some websites as well.
This should be helpful in demonstrating presumption of conformity.
I suppose that this apply to the MDD too, but I’m verifying several harmonised standards (respect to MDD), and I’m not able to find this table, even with other names.
So, my questions:
- is it true that harmonized standards contain such appendix?
- if so, is it possible that when a standard is harmonized, it is updated and that this annex is added later?
- if so, how to recognize an “harmonized” standard respect to a “simple" EN standard, at the moment of buying it?
Thank you in advance for any help.
Cybel
 
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planB

Trusted Information Resource
#2
Cybel,

- is it true that harmonized standards contain such appendix?

Yes, harmonised EN standards contain an Annex Z

- if so, is it possible that when a standard is harmonized, it is updated and that this annex is added later?

Yes, that might be possible.

- if so, how to recognize an “harmonized” standard respect to a “simple" EN standard, at the moment of buying it?

Harmonised standards are published in the OJ. Refer to this page for MDD.

Currently, there are no standards that are harmonised with regards to the MDR. There is only a draft standardisation request that might give you a clue which standards might one day have a Z-Annex related to the MDR.

Hope this helps,
 

Cybel

Starting to get Involved
#4
Hi planB and Jean_B, thank you for your answers, they are very helpful and in the future I will remember to check this in advance.

I know that there are not yet harmonised standards with regards to the MDR, so I've been suggested that the best way to proceed, for now, is to connect each requirement of GSPR (MDR) with each requirement of ER (MDD) which is, at its turn, connected with the requirements of the harmonised standard (under MDD) in order to get a cross-reference between GSPR and harmonised standards.
This make sense for me, so I've looked for this appendix, but I've not found what I've expected to find: I've found only an annex ZZ that generally refers to the coverage of Essential Requirements of EC directive, while I would expected to find a detailed comparison table between the standards and each essential requirement. If it is so, this in not so useful...


annex ZZ.png
 

planB

Trusted Information Resource
#5
Cybel,

a word of caution: MDD-harmonised standards may be outdated and superseded by newer state-of-the-art standard revisions. Under the MDR, you may want to conservatively cross-reference the latest ISO revision of standards in this case. One prominent example is state-of-the-art ISO 10993-1:2018: the harmonised standard EN ISO 10993-1:2009 is outdated and should not be referenced anymore in MDR GSPR checklist.

Generally, the comparison is not too detailed - DIN EN ISO 10993-1:2010 for example, contains this:

1608289543749.png

This thread might also be of use.

Hope this helps,
 

Cybel

Starting to get Involved
#6
Yes, you are perfectly right, thanks for pointing it out.
The table ZA.1 in the DIN EN ISO 10993-1:2010 is better than nothing, should I found it in a state-of-the-art standard it will be a good starting point.
Actually, I have also just found that table in a standard that is not MDD harmonized, so maybe harmonization is not the criteria for the presence of this table or not :unsure::
annex ZA in not harmonised standard.png
Thank you again, for the link to the other thread too.
 

planB

Trusted Information Resource
#7
Cybel,

the process of harmonisation is not very transparent to "outsiders". The example you mentioned shows that this standard was at least intended at some point in time to become harmonised, but the process of harmonisation went astray somehow. One reason could be (but only speculative for your specific example), that the HAS consultant or other stakeholders do not agree with the proposed cross-reference table.

The only authoritative reference of harmonisation is publication in the OJ.
 

Cybel

Starting to get Involved
#8
Oh, good to know. Thanks for your interesting inputs.
I would like to share my attempt of GMDR list, maybe the way it is set up may be useful for someone, even if I suppose the contents may be improved and "compliance notes" made stronger.
 

Attachments

htcoztrk

Starting to get Involved
#9
Hello planB,

My question reffering to below quote from you: As you know the ISO 10993-1:2018 finally harmonized by CEN in December 2020. Although I haven't purchased it yet (due to both economic reasons and DOW 30th June, 2020), as I heard it also contains no Annex Z like many other standards updated during last 1,5 year because they are still working on relation of standard to MDR GSR.
So for my MDD technical file, should I consider the Annex Z of revious harmonized version EN ISO 10993-1:2010 or consider the current EN ISO 10993-1:2020 but specify it does not contain the Annex Z for the current moment? Hope my question is clear enough.

Thank you everyone in advance.
-Hatice
One prominent example is state-of-the-art ISO 10993-1:2018: the harmonised standard EN ISO 10993-1:2009 is outdated and should not be referenced anymore in MDR GSPR checklist.
 

planB

Trusted Information Resource
#10
Sorry, but ISO 10993-1:2018 has _not_ yet been harmonised: just because EN ISO 10993-1:2020 was recently published by European standards organisation CEN does not imply automatic harmonisation. As of today, not a single medical-device standard has been harmonised under the MDR. Still, I would recommend referencing the most recent standard revision, being the recognised state-of-the-art.

Hope this helps,
 
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