UDI-PI requirements on reusable surgical device, do we need serialisation?

#1
Hi,
We are currently adding UDI information across our products and are unsure what we should do.

We manufacture a reusable surgical devices that has an element that is removable and can be autoclaved. The removable element has its own SKU.

We are unclear as to whether or not we are required to serialise the UDI-PI that is permanently marked on the device, we can see benefits to doing so but it will be a major headache logistically (with significant cost implications as well) given the numbers requiring marking and creating unique artwork for the marking sub contractors (I think all stakeholders agree that when we bring the process in house there are tangible benefits to the customer and us to serialising the devices) currently we engrave a human readable code but we are getting feedback from our distributors that they would prefer a machine readable 2D barcode.

So put simply, are we able to stop serialising them temporarily until we bring the process in house?
 
Elsmar Forum Sponsor
#3
On rereading MDR Annex VI part C The UDI system (part 1) Definitions I realise now that I was getting overly hung up on the word unique and taking that to mean that serialisation was required.

It specifically states that "The word ‘Unique’ does not imply serialisation of individual production units. "

However, Annex VI part C The UDI system (part 2)
6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses

6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.

6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.
Seems to suggest that we can define what goes on the reusable element and it is unlikely that a risk assessment would conclude anything other than serialisation being required as multiple probes from the same batch might be in the same kit and/or new probes may be added at a later date and theater staff would need to be able to identify which are sterile and might need to be able to identify which probe has been used on whom, it's also possible that I am over thinking this and thinking of serialisation as a solution to a problem that hospitals don't even know they have!
 

planB

Super Moderator
#4
Device traceability and preventing mix-up of re-usable devices at the healthcare facility is the sole responsibility of the healthcare facility, irrespective of whether you define lot or serial numbers for your devices.
 
Thread starter Similar threads Forum Replies Date
M Supplier requirements - Major supplier is a Non-Profit registered with ICCBBA (FDA UDI) Supply Chain Security Management Systems 12
M MDR Requirements - UDI/Barcodes/QR codes on IFUs EU Medical Device Regulations 4
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 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
S UDI (Unique Device Identification) Requirements for Remanufactured devices 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Understanding UDI requirements - Class 2 medical device (hearing aids) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
S What is the significance of UDI date requirements for Class 1 devices? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Labeling and UDI requirements for medical device kits 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
ernieto UDI requirements - Does a UDI expire? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
Pmarszal Label Printing: Medical Device related UDI Requirements - GUDID Aspects Other US Medical Device Regulations 0
H UDI (Unique Device Identification) Requirements for IVD Software EU Medical Device Regulations 2
D 820.120 UDI (Unique Device Identification) Labeling Verification Requirements Other US Medical Device Regulations 11
I UDI requirements vs Japanese Barcode Marking guideline Japan Medical Device Regulations 1
M Issues with UDI additions to 21 CFR 820 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
J UDI requirements for serialized medical devices with multiple configurations Other Medical Device Regulations World-Wide 11
M UDI (Unique Device Identifier) ISO/IEC 15459 (Unique Identifiers) Requirements Other US Medical Device Regulations 4
K UDI (Unique Device Identification) requirements of US FDA US Food and Drug Administration (FDA) 4
M UDI (Unique Device Identification) Verification Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 9
M Official EU Unique Device Identifier (UDI) Requirements EU Medical Device Regulations 3
W Class II Medical Device Unique Device Identifier (UDI) Requirements US Food and Drug Administration (FDA) 8
A UDI for product already packed up EU Medical Device Regulations 0
M Brand owner or manufacturer responsible for Basic UDI-DI and UDI-DI? EU Medical Device Regulations 2
Aymaneh UDI-PI Software CE Marking (Conformité Européene) / CB Scheme 0
J UDI-DI how should we interpret Device version or model to determine if a new UDI-DI is needed? EU Medical Device Regulations 0
J UDI - Where to document it? EU Medical Device Regulations 8
N UDI: GS1 or HIBC ??? EU Medical Device Regulations 1
F UDI-PI required on packaging (MDR) EU Medical Device Regulations 2
C UDI Questions on Control Units Other US Medical Device Regulations 6
K Two FDA questions regarding UDI (and potentially 803.52 MDR) Other US Medical Device Regulations 0
V UDI - OEM or OBL / Legal Manufacturer Responsibility CE Marking (Conformité Européene) / CB Scheme 0
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 1
K Is UDI (Unique Device Identifier) symbol mandatory under EU MDR? EU Medical Device Regulations 3
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 1
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 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

Similar threads

Top Bottom