UDI transition period and implementation

MedicalDevice

Involved In Discussions
#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!
 
Last edited:
Elsmar Forum Sponsor

rob73

looking for answers
#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

Involved In Discussions
#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.
 
Thread starter Similar threads Forum Replies Date
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
A European UDI-DI CE Marking (Conformité Européene) / CB Scheme 2
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 0
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 1
M UDI procedure/ report 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
R Shall a new UDI-DI be required when stand-alone software device's version is updated? EU Medical Device Regulations 1
D Hospital Decontamination and the MDR - Technical Files, UDI and PMS EU Medical Device Regulations 3
F UDI - Unit of Use and Class I, single-use devices EU Medical Device Regulations 4
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 4
Q Must product name be listed the same name in FURLS, UDI, GUDID and Company Website? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q LOT or Serial Number Symbol not used when the information is contained in the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
J Looking for a template SOP for UDI implementation for EU Medical Devices EU Medical Device Regulations 0
M Basic UDI and technical documentation EU Medical Device Regulations 1
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
M UDI size on packaging EU Medical Device Regulations 3
R UDI for US - Third Party device Repackager Other US Medical Device Regulations 9
M UDI placement - Packaging levels EU Medical Device Regulations 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
M DI format for UDI after we have registered it with GS1 Other US Medical Device Regulations 0
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K China UDI Implementation for October 1st 2019 China Medical Device Regulations 4
A What is the difference between Basic UDI-DI and UDI-DI? EU Medical Device Regulations 6
M UDI-PI on a package that contains more devices EU Medical Device Regulations 3
M Informational EU – Unique Device Identification (UDI) System – FAQs Medical Device and FDA Regulations and Standards News 0
F EUDAMED UDI Medical Devices User's Guide Medical Device and FDA Regulations and Standards News 6
J Class 1 Medical Device - Using a UPC over the UDI? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
Z Do we still have to put UDI if we have DI and lot number seperately on our product ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M EU Basic UDI-DI Trigger Points - When is a new Basic UDI-DI required EU Medical Device Regulations 3
P UDI-PI and the MDR - Is the UDI-PI required for all devices/classifications? EU Medical Device Regulations 8
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
K Hospital UDI requirements Other Medical Device and Orthopedic Related Topics 7
J FDA Class 1 Medical Device UDI requirements Other US Medical Device Regulations 19
J UDI Requirements - Products that all fall under the same family 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M Informational EU – MDCG 2018-1 v2 Guidance on basic UDI-DI and changes to UDI-DI Medical Device and FDA Regulations and Standards News 0
F MDR 2017/745 Basic UDI-DI, UDI-DI & UDI-PI EU Medical Device Regulations 0
M Informational EU – EUDAMED UDI Device Data Dictionary + data sets Medical Device and FDA Regulations and Standards News 0
M EU MDR - UDI requirements and responsibility guidance EU Medical Device Regulations 1
A UDI requirements for pre-filled combination devices - Box containing a pre-filled device US Food and Drug Administration (FDA) 2
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 22
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
Z UDI assignment Criteria Software IVDR Other Medical Device Regulations World-Wide 0
S Looking for procedure on UDI (Unique Device Identification) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
M Medical Device News EU interesting developments – embracing MDSAP and UDI alignment Medical Device and FDA Regulations and Standards News 0
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom