Timeline for harmonised standards to be published under MDR
- Thread starter Angela
- Start date
Do you mean in the OJEU? in 2019 Q2? Q3?
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.
Last edited:
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.
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).
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).
Last edited:
