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MDR "Common Specifications" (CS) - If not standards, then what?

Mark Meer

Trusted Information Resource
#1
I'm hoping someone can elaborate (perhaps with examples) of what is meant by "Common Specifications (CS)" in the MDR.

The definition given is:
(71) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
...and there are some more details in Article 9.

But I'm still not clear what these are... In principle, the concept seems pretty similar to harmonised standards.

Is there an authoritative site where these CSs reside or can be searched? How do I know if there are any that apply to my device?
 
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craiglab

Involved In Discussions
#2
The first CS being worked on is for reprocessing of SUDs. You can download the draft and read comments here:
Single-use medical devices - safety and performance requirements for reprocessing
It is scheduled for release in Q1. The next CS, which is scheduled for release in Q2, is for Products without a medical purpose.
The relationship to harmonized standards is found in Article 9: CS will be adopted where no harmonized standards exist, or where the harmonized standard is insufficient, or where there is a need to address public health concerns. And manufacturers SHALL comply with CS unless they can duly justify an equal or better solution.
 

Mark Meer

Trusted Information Resource
#3
Thanks craiglab, that clears things up a lot. Basically, from what you say, it's something written into the regulations that, at the moment, is not applicable to most manufacturers.

Moving forward however, is there a notification service I can subscribe to specific to CS development/release in order to stay informed as to what might apply to my devices in the future?

...And manufacturers SHALL comply with CS unless they can duly justify an equal or better solution.
Despite the lack of explicit "shall", this is more-or-less how harmonised standards are treated in the industry (in my experience), which is why I say that conceptually, these Common Specifications seem very similar to harmonised standards.
 
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