UDI transition period and implementation

MedicalDevice

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#1
Hi,
I read in the MDR the following sentence concerning the UDI:
"(97) In order to provide for a smooth introduction of the UDI system, the moment of application of the obligation to place the UDI carrier on the label of the device should vary from one to five years after the date of application of this Regulation depending upon the class of the device concerned."

Could someone explain this to me? Does it mean that from the moment that the new MDR is put into action (May 2020), there will be a 5year transition period where the companies will be able to implement it (according to their class)?
If yes, does anyone know what the timeline is for implementing the UDI for each class? (I am mostly interested in class IIb).
Thank you in advance!
 
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rob73

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#2
If i understand it right the following applies:
Article 123 "(f) for implantable devices and for class III devices Article 27(4) shall apply from 26 May 2021. For class IIa and class IIb devices Article 27(4) shall apply from 26 May 2023. For class I devices Article 27(4) shall apply from 26 May 2025;"
Article 27(4) "UDI carriers shall be placed on the label of the device and on all higher levels of packaging. Higher levels of packaging shall not be understood to include shipping containers."
So for Class 2a and b it applies form 26 May 2023. although some regions are cutting this short, the British NHS want UDI's/barcodes well before this date.
 

RA_QA_Expert

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#5
Hi, you need to be UDI ready and have UDI process in place by May 26, 2020 at latest.

The transition period (article 123) gives us "only" some time (based on the risk class) when we need to have UDI carrier on the device, label and/or packaging.

It does NOT mean, that e.g. if I'm class I medical device manufacturer, I have time until 2025 to start with UDI process :)
 

MedicalDevice

Involved In Discussions
#6
Hi, you need to be UDI ready and have UDI process in place by May 26, 2020 at latest.

The transition period (article 123) gives us "only" some time (based on the risk class) when we need to have UDI carrier on the device, label and/or packaging.

It does NOT mean, that e.g. if I'm class I medical device manufacturer, I have time until 2025 to start with UDI process :)
To my understanding, I thought that we needed to start the application process by May 26, 2020 (and then have it implemented until e.g. 2025, according to our class).
 

SKM.Sunil

Involved In Discussions
#7
The UDI requirement depends on the risk of your product. So more there is a risk, sooner you should implement it.
Below are the implementation dates following the class:
Class I: 26 May 2025
Class IIa and IIb: 26 May 2023
Class III: 26 May 2021
Implantable devices: 26 May 2021

For Reusable devices, The UDI carrier should be on the product and as there are some products that will be already on the market, the European Commission is delaying it´s implementation to 2 years later (Depends on the class).
If the reusable product is in class III, then the implementation of UDI is delayed to 26 May 2023.
If it´s classification is in class I, then this can be implemented until 26 May 2027.


I would suggest you implement it with your device upon certified "CE" under MDR. That is most safe in future to deal with "post market data" and NB surveillance audits.
 
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