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Which EN ISO 17664 version compliance to EU MDR?

N

Nanda06

Registered
#1
#1
Hello,

Regrading ISO 17664 standard, as per the CEN latest standard is EN ISO 17664:2017 and as per the EU Official Journal version is EN ISO 17664:2004.

Kindly suggest me, which version of standard shall comply to meet the EU MDR requirements?

Reg
Nanda
 
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planB

planB

Trusted Information Resource
#2
#2
Nanda,

currently, no harmonised standards are available for the MDR, so best to use state-of-the-art standards, which are typically the latest revision, in your case EN ISO 17664:2017.

HTH,
 
N

Nanda06

Registered
#3
#3
Hello,

Thanks for your reply...

We have already complied the EN ISO 17664:2004, do we need to submit the EN ISO 17664:2017 report during MDR submission?

As you said no harmonized standards are available for the MDR, is old version is sufficient to meet the MDR requirements?

Kindly clarify ...

Reg
Nanda
 
planB

planB

Trusted Information Resource
#4
#4
Nanda,

The MDR says in ANNEX I, Chapter I, General Requirements:

Devices shall achieve the performance intended by their manufacturer [...], taking into account the generally acknowledged state of the art.
Click to expand...
So there is a high chance that your notified body will ask you for compliance to the latest revisions of standards you employ for your submission. One option to demonstrate continued compliance is to perform a gap analysis between the current and the superseded standard revision and address all identified differences in a documented way for your product. In case you identify the gaps as being not significant, you may succeed in establish continued compliance as outcome of this gap analysis.

HTH,
 
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