MDR standards - which standards to comply with ?

rini_ch

Registered
Hello All,

I was in a notified body webinar yesterday in which they suggested that they will accept compliance to harmonized standards in MDD as part of MDR complaince, applying the latest published standards is not mandatory. MDR states that it should either be harmonised standard (as I understand there are no harmonised standards against MDR yet) or state of the art. Is it safer to comply with all the recently published standards because they would be state of the art ? Some of the standards dont have a TRF because IECEE has not published a TRF ? Any guidance will be really helpful.
 

shimonv

Trusted Information Resource
Your guess is as good as anyones. My personal inclination is not to run a head of the regulator; there is so much to do anyways.
I would go with the currently harmonised standards and keep an eye for recently published standards. If you could do a gap analysis that would be best because then you could make an intelligent decision about wether or not to comply with the state of the art standards. I'm sure the notified bodies would be pleased with this approach.

Shimon
 

Ronen E

Problem Solver
Moderator
In addition to Shimon's answer, I'd suggest to follow whatever guidance your own NB (i.e. the one that will actually audit and certify you) gives you - since there's a lot of uncertainty around the MDR, different NBs may have different interpretations and practices.
 

dgrainger

Trusted Information Resource
To be in compliance, you need to meet the GSPRs - so you need to perform gap analysis of ERs vs GSPRs taking into account what the harmonised standard says about how MDD ER's are met. Some are effectively unchanged:) - others completely new:confused:
 
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