Timeline for harmonised standards to be published under MDR

#1
Hi All,

I was wondering if anyone had heard anything recently on when the harmonised standards will be published under the MDR 2017/745?

Thanks

Regards,
Angela
 
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Marcelo

Inactive Registered Visitor
#2
The draft of the first standardization mandate was circulated some time ago to stakeholders for comment, and should be published in a while.
 
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Marcelo

Inactive Registered Visitor
#4
The draft standardization mandate should be published (it was going to be published in March, so it's late). After that, the standards have to be created (most are already published), then the CEN consultant has to evaluate them to identify if they can give presumption of conformity, then he makes the report, then it will be revised, then it can be published. It may take a while.
 
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Ronen E

Problem Solver
Staff member
Moderator
#5
Wow. I wasn't aware that they are so much behind. Sounds like the OJEU publication won't happen before 2020. Hopefully before May 2020!...
 

Marcelo

Inactive Registered Visitor
#6
The main problem is that the first mandate as drafted only includes process standards, not product standards. Another mandate will be required if it goes like this.

Wow. I wasn't aware that they are so much behind. Sounds like the OJEU publication won't happen before 2020. Hopefully before May 2020!...
The process is really somewhat obscure, but you can read it here: Vademecum on European standardisation (the Blue Guide has some information, but not enough).
 
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