By when should harmonized standards be complied with?

cool1984

Starting to get Involved
#1
Hi, all.

I found "DECISION (EU) 2022/6".
Note) I'm sorry, but I just registered recently, so I can't seem to get the link yet. Please refer to this source by replacing "*****" in the following address with "https".
*****://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX:32022D0006#ntc5-L_2022001EN.01001101-E0005

According to the above sources, the harmonized standards such as EN ISO 13485:2019+A11:2021, EN ISO10993 series, EN ISO15223:2021 have been added to EU MDR.

By when do you need to comply with these harmonious standards?

Note 1: Our product is a class 1 device that does not require NB involvement.

Note 2: I asked the same question in another thread, but I moved the question because this thread seems to be more relevant.

Thank you.
 
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shimonv

Trusted Information Resource
#2
Not all implementation decision includes deadline for the adoption which is regrettable.
To get some idea have a look at the attached COMMISSION IMPLEMENTING DECISION 2406.

Regardless of your product class, you need to do a gap assessment and implement before the adoption date. Since you are a class I manufacturer, you don't have the NB breathing down your neck.

Shimon
 

Raisin picker

Quite Involved in Discussions
#3
I have heard that at least for some of these standards, the differences are only in the annexes.

For DIN EN ISO 13485, the differences from :2016 to :2021 are that the Annexes ZA, ZB and ZC have been replaced with (informative) new ZA and ZB. They basically replace the references to MDD, AIMDD and IVDD with references to MDR and IVDR. No deadline applies, they are instantly applicable. This information comes from our internal RA department.
 

Junn1992

Quite Involved in Discussions
#4
Yea I would assume they are instantly applicable as well. Of course the caveat is that you do not necessarily have to follow the Harmonised Standards to show conformity, although HS do offer a presumption of conformity in general.
The 13485 you listed is the EN version with annexes ZA ZB, but if you just follow ISO version 13485:2016 it is accepted as well. Overarching QMS standards like ISO 13485 etc, and the labelling information in ISO 15223 are pretty straightforward to comply with, assuming you already have proper QMS in place. The problem, as shimonv pointed out, is with technical standards that require some sort of product testing. As such, for such standards requiring some sort of test, it is always advisable to be updated to the 'state of the art'. This is the general approach I would advise. It's good to ask your NB too, they might have some 'info' on when latest standards become official HS.
 
#5
Let's say currently i am certified under ISO 13485:2016, in order to move on to EN ISO 13485:2016+A11:2021, what are the additional SOP do i need to include ? Clinical evaluation, PMS, UDI, UA.. ? Kindly advise..Thanks
 

Junn1992

Quite Involved in Discussions
#6
Let's say currently i am certified under ISO 13485:2016, in order to move on to EN ISO 13485:2016+A11:2021, what are the additional SOP do i need to include ? Clinical evaluation, PMS, UDI, UA.. ? Kindly advise..Thanks
The additional annexes under A11 are talking about how the ISO 13485 standard relates to the MDR/IVDR. It will highlight differences in certain clauses of the standard as it relates to the MDR/IVDR, and how one should apply the ISO 13485 standard to be compliant to the MDR. You should really purchase the standard and read through the MDR carefully to make sure you meet all the requirements
 
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