UDI and Labelling hierarchy and requirements for separate device components

[jansayshello]

Hello,

I have questions which I hope someone with similar experience of this situation can help answer.

The company I work for is involved in the development of several medical devices which are intended to be placed on the GB market, and could be placed on the EU market subsequently.

We are mindful that current GB Medical device regulations (UK MDR 2002, transposing requirements from 93/42EC, as amended) may change in the near future to align more closely to requirements from the EU MDR 2017/745, and as such, are ensuring that our UDI systems are in place – now.

Many of these "devices" are "systems" comprised of a piece of hardware (a product making physical contact with a patient) which is wirelessly connected to software (required for the device to deliver the system's intended medical purpose) installed on a separate, supplied, mobile device such as a locked-down tablet pc (accessory).

The hardware may also have a charging unit as an accessory to the system.

We design and manufacture the hardware (and its firmware), app software, and supply the mobile device together in a carry kit.

For the purpose of my questions, let's also make the following assumptions:

• The combination of these "products" are only intended to be sold together as one system (i.e. system components are not sold individually).
• However, some system components may be supplied to a customer only as a replacement in the event of a fault with that component (e.g. replacement charging unit).
• The "system" has a Product Code, which is based on the manufacturing assembly number.
• The "system" has a GTIN (13-digit with a leading 0 to make 14 digits) as a (Basic) UDI-DI.
• Each "loose" system component - i.e. the hardware, charging unit, tablet PC, software has a product code which is based on its manufacturing assembly/part number.

Questions:

1. Does each "loose" system component require its own unique (Basic) UDI-DI (i.e. a GTIN number) and labelling, where the whole system is also "packaged" with a label containing the system UDI-DI?
2. Or does each system component require a label, but this label contains the same content as its parent system?
3. If the answer to 1. is yes, does this only apply to the system components which are intended to be supplied as spare/replacement components, or does it apply to all components?

Thanks in advance,

Jan

 

[Junn1992]

The company I work for is involved in the development of several medical devices which are intended to be placed on the GB market, and could be placed on the EU market subsequently.

Do note UKCA mark does not equal CE mark. And, if I recall correctly, you can use CE mark OR UKCA for northern ireland.

Does each "loose" system component require its own unique (Basic) UDI-DI (i.e. a GTIN number) and labelling, where the whole system is also "packaged" with a label containing the system UDI-DI?

Yes, if they are accessories under the MDR. I can't say for UK (not familiar with the new UK regulations). So your hardware would have one BUDI and UDI, software have one BUDI and UDI, and the entire pack itself will have its own UDI.

Or does each system component require a label, but this label contains the same content as its parent system?

No. Each component in its own will have its own BUDI and UDI labelling. The MDR specifies each level of packaging to have its own UDI.

If the answer to 1. is yes, does this only apply to the system components which are intended to be supplied as spare/replacement components, or does it apply to all components?

Applies to all accessories under the MDR.
Each accessory has its BUDI and UDI
Entire pack is its own BUDI and UDI as well. (I refer to MDCG 2018-3 Section 4)

Do correct me if my understanding is wrong.

 

[jansayshello]

Hi

Thanks for kindly replying, we're aware of the different UKCA, UKNI and CE implications for GB (England, Scotland, Wales) and EU & NI respectively.

Do note UKCA mark does not equal CE mark. And, if I recall correctly, you can use CE mark OR UKCA for northern ireland.

By the way, for GB-based (England, Scotland, Wales) manufacturers, a CE and UKNI mark together are required for access to the NI market from 1st January 2022, if conformity-assessing with a UK-approved body. (Or just CE if using a EU-based notified body, overseas)

Thanks for the MDCG 2018-3 document link - very helpful.

 

[Junn1992]

a CE and UKNI mark together are required for access to the NI market from 1st January 2022, if conformity-assessing with a UK-approved body. (Or just CE if using a EU-based notified body, overseas)

Hi Jan! We are CE marked but not based in EU or UK. So does that mean starting this year, if we want to enter the UK market, we need UKCA mark only since we can access NI with CE? Our NB is located in the EU.

 

[jansayshello]

Hi Junn

Thanks for your message.

I believe Great Britain will still continue to recognise CE-marked medical devices until 30 June 2023. However if the legal manufacturer is not based in GB, I believe a "UK responsible person" is required (the GB equivalent of an EU-authorised rep) now and registration with the MHRA is required.

My point above was about your comment on the UKCA mark applying in Northern Ireland, which technically isn't correct. The UKCA mark is different from the UKNI mark, as although Northern Ireland is part of the United Kingdom (UK), following Brexit it was agreed as part of the Northern Ireland Protocol that medical devices sold in Northern Ireland need to meet EU requirements. By the way, the UKNI mark is never used on its own - it needs to accompany a CE mark.

For clarity:

United Kingdom (UK) = England, Scotland, Wales, Northern Ireland

Great Britain (GB) = England, Scotland, Wales
UKCA marking based on conformity to UKMDR2002 S.I. no. 618 (transposing requirements from 93/42 EC (MDD), as amended) applies here currently, although CE marked products will be recognised until 30 June 2023

NI = Northern Ireland
UKNI and CE marking (If using a GB-based "approved body") or just CE marking (if using an EEA (including EU), Switzerland and Turkey-based notified body) based on conformity to the 2017/745 (EU MDR) applies here.

There are GOV.UK web pages which explain this clearly (and probably better than I have) – unfortunately I'm not allowed to post links here yet as I'm new to posting on the forum! Search for UKCA mark UKNI mark GOV UK and you should find them.

Jan

 

[Junn1992]

Hi Jan! Thanks for the reply, it is very clear to me now. I actually attended a short talk on this, but after the talk I was still confused. Great clarification

 

[jansayshello]

For anyone following this thread, my original questions can be part-answered by clause 6.2 of ISO 20417:2021:

6.2 Identification requirements for detachable components of a medical device or accessory
If misidentification can result in an unacceptable risk, detachable components of a medical device or accessory shall be labelled with all of the following....

I suppose I'm still unclear as to how (or why?) you might go about labelling the parent "system" information on the individual component as well as the individual component information, as the individual component (in our case) has its own part reference, which is the catalogue number.

Can you have two catalogue number references on the same label? Is there a conventional way of differentiating between parent and child information?

 

[Junn1992]

For anyone following this thread, my original questions can be part-answered by clause 6.2 of ISO 20417:2021:


I suppose I'm still unclear as to how (or why?) you might go about labelling the parent "system" information on the individual component as well as the individual component information, as the individual component (in our case) has its own part reference, which is the catalogue number.

Can you have two catalogue number references on the same label? Is there a conventional way of differentiating between parent and child information?

Hmm...according to MDR each level of packaging shall bear its own unique UDI. I think this is an ISO 20417 specific requirement.

But how to indicate on the packaging that an accessory is part of an entire system? Maybe with pictograms? Not too sure myself