UDI labeling MDR requirement for reusable medical device accessories

med_cert

Involved In Discussions
#11
Is there enough if only UDI-DI is placed on the higher leveles of packaging? It does not make any sense for UDI-PI for higher level of packaging... or?
 
Elsmar Forum Sponsor

snowball852

Starting to get Involved
#12
So you believe each accessory AND accessory part (which can be removed during re-processing) need an non-removable UDI carrier...?
Paragraph 3.6 of the Annex states "Each component that is considered to be a device and is commercially available on its own shall be assigned
a separate UDI unless the components are part of a configurable device that is marked with its own UDI."

So I would say not necessarily. If the components cannot be considered a device on their own, then you do not need a UDI on each component.
 
#13
Facing a similar challenge with respect to interpretation of UDI guidelines.

Our device is a class I reusable device, supplied with a reusable accessory. These two components share the same UDI-DI. The package containing the two devices has been assigned a separate UDI-DI.

In order to use the device, a single use accessory must be attached, the accessory has no use other than when used with the device.

The accessories are supplied separately, are packaged individually and supplied in boxes of 25. Should the UDI-DI for the accessory be the same as the reusable components?

Any input would be much appreciated. Reading the GS1 general specifications document this morning has severely impaired my ability to think straight :)
 
Thread starter Similar threads Forum Replies Date
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
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
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
K UDI Labeling for Medical Device Samples 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
T UDI Labeling of Convenience Kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Q UDI- RFID Labeling Other US Medical Device Regulations 4
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
K UDI Labeling for Clinical Investigational Device Other US Medical Device Regulations 3
Pmarszal UDI (Unique Device Identification) Transition Period - Packaging Labeling Other US Medical Device Regulations 5
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
M GUDID/UDI Packaging and Labeling Questions Other US Medical Device Regulations 6
F UDI Registration - Who is responsible for Registration of the Device? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
M UDI Database and EUDAMED - Will there be two separate databases? EU Medical Device Regulations 3
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
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
M UDI transition period and implementation EU Medical Device Regulations 6
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
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 5
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 4
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
N EU MDR Basic UDI-DI and Technical Documentation for Systems EU Medical Device Regulations 20
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 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