MDR Legacy Medical Device Labeling compliance timeline

#1
Hello,

I am trying to understand the timeline of labelling compliance to the MDR. I assumed all products that are available on the market need to have MDR compliant labelling after the 26th of May 2020.
Now my colleague has told me that these devices, which were placed on the market in 2018, can keep the old labelling for another couple of years. Who of us is right?

Thank you all in advance for your help.
Martin
 
Elsmar Forum Sponsor

kunal9218

Starting to get Involved
#2
Hello,

I am trying to understand the timeline of labelling compliance to the MDR. I assumed all products that are available on the market need to have MDR compliant labelling after the 26th of May 2020.
Now my colleague has told me that these devices, which were placed on the market in 2018, can keep the old labelling for another couple of years. Who of us is right?

Thank you all in advance for your help.
Martin
As far as I know, all the devices needs to be certified in order to sell in EU. That is why we are remediating labels right now to meet the deadline. We are just submitting the draft labels though.
 

Marcelo

Inactive Registered Visitor
#4
Hello,

I am trying to understand the timeline of labelling compliance to the MDR. I assumed all products that are available on the market need to have MDR compliant labelling after the 26th of May 2020.
Not true. If your device keeps being compliant with the Directives, you need to comply with the directives, not the regulation (the only exemptions are the PMS and registration requirements, which will be applied after 26th of May 2020 regardless if your device complies with the directives or the legislation).

All other devices that are under the MDR are required to comply with the MDR in full, including labeling.

Hello,
Now my colleague has told me that these devices, which were placed on the market in 2018, can keep the old labelling for another couple of years. Who of us is right?
If you have a device with a certificate (with NB involvement) you can keep the device under the directives for the time of certificate validity as long as you comply with Article 120 of the MDR (which details the requirements for "legacy devices under the directives).
 
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