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Rumours that class 1 NS, NM, NR devices will have a new deadline for MDR compliance

#1
Hi all

I am hearing rumours that class 1 NS, NM, NR devices will have a new deadline for MDR compliance - not May 2020

Can anyone on here validate this?

Thanks
James
 

Watchcat

Quite Involved in Discussions
#2
I'm more inclined to validate Bassil Akra's comment on LinkedIn, which is also being spread around the internet:

Rumors Rumors Rumors...

I am recognizing a lot of posts and promises regarding the transition period of the Medical Device Regulation. Please be aware that nothing is officially published nor confirmed yet. A press communication is legally not binding. If the commission will not publish a corrigendum or other legal documents addressing this aspect, the transition period for class I reusable surgical instruments remains unchanged.
 

Mikilk

Starting to get Involved
#3
I'm more inclined to validate Bassil Akra's comment on LinkedIn, which is also being spread around the internet:

Rumors Rumors Rumors...

I am recognizing a lot of posts and promises regarding the transition period of the Medical Device Regulation. Please be aware that nothing is officially published nor confirmed yet. A press communication is legally not binding. If the commission will not publish a corrigendum or other legal documents addressing this aspect, the transition period for class I reusable surgical instruments remains unchanged.
Transition period for Class I nonreusable/sterile/measuring function as well - this is a massive amount of manufacturers most of them do not really understand the changes
 

Marcelo Antunes

Addicted to standards
Staff member
Admin
#4
Yes, the rumors ara happening. Is this what you want validated?

If if you validation on the deadline itself, unfortunately you won't get it, because it depends on official positions, and there's no official position yet.
 
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