Labeling a Small Class IIb Medical Device

M

mr.mike

#1
Hi There!

Wondering if anyone can offer some advice as to labelling a small medical device.

The device is a wireless earpiece, much like a bluetooth ear-clip.

So, my question is: what exemptions can be made for small devices?

Most of the information required by the MDD will be in the instructions for use booklet.

The MDD (annex I, section 13) uses "where appropriate..." several times. Can this be interpreted as "where space permits..."?

We'd like, at minimum, a serial-number on the device somewhere (so we can identify it). ...but is it necessary that such a number be immediately visible by the user? For example, is is permissible to place the label on the inside of the device (so it can be accessed only by opening the casing).

Any advice, links etc. greatly appreciated.

Thanks in advance,
MM.
 
Elsmar Forum Sponsor
P

phloQS

#3
Re: Labelling a Small Class IIb Medical Device

Hi mr. mike,

The CE-mark for example should have at least a height of 5mm. So when it is not possible (this is always discussible; if just a cool look is the reason why there is no space, then I would not accept this; if there is no space because of the functionallity e.g. a stent must be very small, where to print a CE with 5mm on it, I would accept it) to print it on the device due to space problems, you are allowed to print the mark on packaging an ifu. Your interpretation of "where appropriate" is correct.
If the number must be immediatly seen by the user depends on your risk management in regard to vigilance. I can not imagine a situation where immediate access to the sn would be necessary. Symbols like "see ifu" or "attention" (EN 980) would be great and IMHO there is always a possibility to print such somewhere on the outside of the device.

Regards,

phloQS
 

rob73

looking for answers
#4
Re: Labelling a Small Class IIb Medical Device

Mike
I would suggest at a minimum the product part number and serial number be on it some where ("information necessary for user to identify the device"). If this is on an internal label, as long as you state in the IFU the location (in case of recall etc.) there maybe no issues. The CE and notified body number must be on the device to be placed on the market in the EEC. Have you asked your notified body for help? With advances in laser marking etc I am sure that the size of the device becomes less of a problem. Just looking at a microSD card there is a lot of information packed into a very small space (5mm x 5mm ish).
Rob
 

pkost

Trusted Information Resource
#5
Re: Labelling a Small Class IIb Medical Device

You should identify the details that should appear on the device; risk assess them for priority and identify what could be placed on label and doesn't need to be kept with the device.

When deciding if the information needs to be readable by the end user you should consider what the information is used for...a batch code is useless to an end user so this can be really small, a warning that the device will injure them if used in a certain way obviously needs to be clear!

I don't fully agree about "cool look" being a poor excuse for excluding a CE mark on the device - devices that can be seen and highlight a disability can be better if they are "cool" - there will be improved compliance in their use etc - think glasses, hearing aids etc.
 
M

mr.mike

#6
Re: Labelling a Small Class IIb Medical Device

The CE and notified body number must be on the device to be placed on the market in the EEC.
Are there no exceptions here? The device is basically hearing-aid sized. Surely there must be allowances for devices so small.

I don't fully agree about "cool look" being a poor excuse for excluding a CE mark on the device
Yes, I'd like some more input on this issue. The bulk of "free space" on the device in question is unfortunately on the exposed side (the side visible to everyone if you are wearing it).

Our marketing department (for good reason) would not approve this visible space being cluttered with NB info, and EN symbols. Surely there has to be some consideration/allowances when is comes to the aesthetics, particularly for devices intended to be worn in public...

Any thoughts?
 

Ronen E

Problem Solver
Staff member
Moderator
#7
Re: Labelling a Small Class IIb Medical Device

A few remarks:

- As a general rule, it's allowed to place required labelling on the immediate packaging when placing it on the device itself is impractical (size is probably the most common reason but it's not the only recognized cause). I'm not aware of formal priorities, i.e. info X must appear, then if some room is left include Y, then Z etc.).

- Particularly with regards to the CE mark (and NB number as applicable) - I can't see why this would have higher priority than, say, a caution mark or the "consult instructions for use" symbol. The primary purpose of the CE mark is to enable free movement of (legally distributed) goods into and throughout the EC market, and as such its primary use is during distribution and introduction to use. To that end I fail to understand why placing the CE mark on the immediate packaging would not suffice, especially when there are compelling reasons not to place it on the device itself.

- I find placing the only device identifier (in this case the SN) on the inside detrimental, unless the nature of the device is such that the user would be expected to open / disassemble it anyway, during the course of normal use - apparently this is not the case discussed here. The reason is that the user must be able to identify the specific unit (in terms of model and maybe batch) should a recall notice be issued. You can't expect a user to disassemble such a device upon publication of such notice, right? It'd be a shame to have to collect all units of a certain model when only certain batches are suspected, simply because the users couldn't readily identify whether or not their units belong to such batches!... At the very least, you'd have to also place the SN (and maybe batch #) on the immediate packaging, and urge the user (maybe in the IFU) to keep note of it in a safe place for the duration of owning the device.

Cheers,
Ronen.
 

somashekar

Staff member
Super Moderator
#8
Re: Labelling a Small Class IIb Medical Device

Yes, I'd like some more input on this issue. The bulk of "free space" on the device in question is unfortunately on the exposed side (the side visible to everyone if you are wearing it).
Our marketing department (for good reason) would not approve this visible space being cluttered with NB info, and EN symbols. Surely there has to be some consideration/allowances when is comes to the aesthetics, particularly for devices intended to be worn in public...
Technology is available to print / etch on any surface that is readable only with purpose from a specific angle . These are otherwise not visible to the onlooker. You have to trade-off between regulatory and marketing and put vital information on the device as much as possible, to the benefit of the user's safety and effective use. These have to come out of design and this is the reason why marketing / regulatory have a vital role in the design review process.
 

pkost

Trusted Information Resource
#9
Re: Labelling a Small Class IIb Medical Device

- I find placing the only device identifier (in this case the SN) on the inside detrimental, unless the nature of the device is such that the user would be expected to open / disassemble it anyway, during the course of normal use - apparently this is not the case discussed here. The reason is that the user must be able to identify the specific unit (in terms of model and maybe batch) should a recall notice be issued. You can't expect a user to disassemble such a device upon publication of such notice, right? It'd be a shame to have to collect all units of a certain model when only certain batches are suspected, simply because the users couldn't readily identify whether or not their units belong to such batches!... At the very least, you'd have to also place the SN (and maybe batch #) on the immediate packaging, and urge the user (maybe in the IFU) to keep note of it in a safe place for the duration of owning the device.
You're correct with this - I was thinking too narrowly, with implantables or devices where the medical professional would be the main point of contact in the event of recall and would also maintain a list of devices implanted.
 
Thread starter Similar threads Forum Replies Date
K GHS (global harmonized system) Labeling requirements for Small Packages Occupational Health & Safety Management Standards 2
A Purchasing Controls on Change Management of Literature/Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
S Registration of Medical Device in Hong Kong - labeling requirements Other Medical Device Regulations World-Wide 0
D Hazard symbols and labeling ISO 13485:2016 - Medical Device Quality Management Systems 1
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
D Labeling requirements for reagents, etc ISO 13485:2016 - Medical Device Quality Management Systems 4
N FDA UDI - Label vs. Labeling - Does the insert need to include UDI? Other US Medical Device Regulations 1
Anonymous16-2 Labeling Question (Dietary Supplements/Food) Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 1
L Medical-grade power adapter labeling Other US Medical Device Regulations 2
Y Labeling difference for storage and operating conditions EU Medical Device Regulations 1
H MDD Article 12 Labeling for Class IIa Medical Device - Please Advise EU Medical Device Regulations 3
K China Medical Device Labeling requirements - Language China Medical Device Regulations 3
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
N Device Labeling - Medtronic Ventilator Files (Risk Management documents) Coffee Break and Water Cooler Discussions 2
JoCam Labeling to Customer Requirements EU Medical Device Regulations 1
Z Labeling for Medical Device Samples - Surgical instruments 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
A UDI and Design Controls - Labeling change via the Design Control process 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Change Control - Product Name Change and its associated labeling EU Medical Device Regulations 7
D Do User Manuals (Not Device Labeling) HAVE to be in their national languages for these countries? Will English Hardcopy not do? EU Medical Device Regulations 12
S How to decide which medical device symbols go on label and labeling? US Food and Drug Administration (FDA) 5
M MDR Legacy Medical Device Labeling compliance timeline EU Medical Device Regulations 3
M Informational US FDA Draft Guidance – Breast Implants – Certain Labeling Recommendations to Improve Patient Communication Medical Device and FDA Regulations and Standards News 0
M Labeling for off-label use - Prevention of off-label use of a medical device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
M Informational US FDA Final Guidance – Coronary, Peripheral, and Neurovascular Guidewires – Performance Tests and Recommended Labeling Medical Device and FDA Regulations and Standards News 0
M Informational US FDA Final Guidance – Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings – Labeling Considerations Medical Device and FDA Regulations and Standards News 0
P UDI labeling for power module IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
A Labeling - 2017/745 - EUMDR Requirements and Trademark Issues EU Medical Device Regulations 0
DitchDigger UDI, Labeling Accessories, General Insanity, Etc. US Food and Drug Administration (FDA) 1
K Labeling requirements - Date of manufacture for software devices EU Medical Device Regulations 5
E Annotated US Prescribing Labeling US Food and Drug Administration (FDA) 0
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
M Informational US FDA draft guidance – Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment Medical Device and FDA Regulations and Standards News 0
T Labeling Requirements - Creams in tubes EU Medical Device Regulations 3
K EU MDR Art. 22 - Device + insertion pack - User manual and Labeling EU Medical Device Regulations 4
M MDR 2017/745 sterile and non-sterile labeling EU Medical Device Regulations 12
M Professional Use Medical Software French Labeling for Canada -- Not Considered Medical Device Canada Medical Device Regulations 2
CPhelan Labeling template on QMS - Kitting and labeling documentation Manufacturing and Related Processes 9
G FDA UDI markings "label" vs. "labelling" (labeling)? US Food and Drug Administration (FDA) 4
G How is the labeling of units cleared for both Rx and OTC uses handled? US Food and Drug Administration (FDA) 4
E FDA Supplier Labeling Requirements ISO 13485:2016 - Medical Device Quality Management Systems 1
L Class IIa Medical Device, CE Mark & 510k - Labeling Content CE Marking (Conformité Européene) / CB Scheme 4
M Scrubbed version of a labeling procedure that is MDR compliant wanted EU Medical Device Regulations 3
M UDI labeling MDR requirement for reusable medical device accessories EU Medical Device Regulations 12
T Change to Country of Origin on Medical Device Labeling Other Medical Device Regulations World-Wide 0
L EU-MDR-Annex I - 10.4 (CMR & Endocrine-disrupting properties) - Labeling Content EU Medical Device Regulations 5
I Medical Device Packaging Multilingual Labeling EU Medical Device Regulations 3
T FDA proposed labeling standalone software cloud based US Food and Drug Administration (FDA) 4
M Putting AR's name and address on label - Authorized Representative Labeling Requirements CE Marking (Conformité Européene) / CB Scheme 0
N IFUs with promotional labeling Other US Medical Device Regulations 0
I Requirements for different Labeling Levels 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2

Similar threads

Top Bottom