MDD vs MDR

[destroyed9218]

Hi, I have a current situation where we havew MDR ready labels as we were going to submit our device under MDR but now the business decision is to register under MDD as change to MDR at a later point.

I want to understand the impact on labels- do I need to change my labels and remove the MDR information from them? like MD symbol. Any other things to keep in mind? what about the technical documentation part of view?

Thanks!

 

[DanMann]

While the MD sybmol isn't in ISO 15223-1:2016, I wouldn;t be too concerned about it appearing on an MDD medical device; it's still state of the art in 15223-1:2021. I'd probably raise a deviation for this specific aspect.
However, what I would not do is provide anything (e.g. IFU) stating the device is compliant to MDR if it is not registered as such.
You should do the Essential Requirement Checklist for the technical documentation, but nothing stopping you from doing a GSPR at the same time.
I'm assuming this is a non-significant change to an existing device rather than a new device as it's no longer possible to register a new device under MDD or make a significant change to an existing device.

 

[ruthroper]

Hi, I have a slightly different question on the same topic and was hoping for some advice.
We are transitioning to the MDR with ISO 15223-1:2021 compliant labelling but we have products in stock under our MDD certificate which are compliant to ISO 15223-1:2016. As far as I can determine there is no deadline to transition to the 2021 standard and we can continue to sell products with 2016 labelling, is this correct?
Many thanks for any advce.

 

[DanMann]

In the EU (plus UK), my understanding is that historically, they (CEN/CENELEC?) would set a withdrawal date (typically 3 years after the publication of the replacement standard) after which time you should have transitioned to the new standard; however, whil we're in transition for MDR, my understanding is that the MDD harmonised standards list (Consolidated TEXT: 32020D0437 — EN — 15.04.2021) is not being updated and anything on it will remain valid for MDD-certified products and anything for MDR will be added to the MDR harmonised standards list (https://ec.europa.eu/docsroom/documents/55101) as EN ISO 15223-1:2021 has been.
In summary, I think you're fine continuing to apply 15223-1:2016 to your current product, but also wouldn't be challenged for transitioning to 2021 if you wanted yo ahead of your MDR certification.
This seems to be partially backed up by the Estonian Standards Agency with their comments on presumption of conformity on their page on this standard:

EVS-EN ISO 15223-1:2016

Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements (ISO 15223-1:2016, Corrected version 2017-03)

www.evs.ee

 

[ruthroper]

Thanks for your reply, that is really helpful. Regards, Ruth

 

[TomQA]

Hello I also have an MDD vs MDR labeling question concerning the UDI (more the UDI-DI).
If the design of the device does not change, is it possible to have the same UDI-DI for MDD and for MDR ?
Or the MDR transition imposes to have a change in UDI-DI on the label ?
Thanks !

 

[EmiliaBedelia]

Hello I also have an MDD vs MDR labeling question concerning the UDI (more the UDI-DI).
If the design of the device does not change, is it possible to have the same UDI-DI for MDD and for MDR ?
Or the MDR transition imposes to have a change in UDI-DI on the label ?
Thanks !

You can keep the existing UDI-DI. As long as your internal systems are capable of controlling "MDD" and "MDR" product (by lot, serial, batch, etc) you don't need a new DI.