I'm hoping someone can elaborate (perhaps with examples) of what is meant by "Common Specifications (CS)" in the MDR.
The definition given is:
...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?
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?