UKCA symbol, CE mark, etc on sterile packaging

[dr1vn]

So we manufacture a sterile medical device that we plan on selling globally. We package the device and gamma-sterilize it in its labeled pouch. As we would like to avoid relabeling or doing country-specific packaging, we're trying to find a way to include all labeling requirements on the pouch. So, a couple of questions:

1. When we go into the EU and UK, would we need both a CE mark and a UKCA mark on the pouch?
2. When we go into the EU and UK, would we need both the EU and UK rep name and address on the pouch
2. How does everyone handle future-proofing yourselves for new markets. I worry that putting so many symbols and names and addresses of the various authorized reps onto a pouch will introduce more risk as it will get very confusing having all that info.

 

[StepPCHen]

Hello,
I get asked this question a lot due to my location being in Northern Ireland. In short, you can place both CE and UKCA side by side and you will need to have the EU & UK reps contact details included, also the correct symbols. At a point in the future, this may not be allowed once the UK stops accepting CE marked devices.

Where are you based in the world just out of curiosity? Have you considered outsourcing the manufacturing process i.e., contract manufacturing?

 

[Dofolo]

1 -> yes, there's no arm in having invalid icons (CE) for the UKCA market, once they stop accepting CE for your device class/certification type. Likewise the UKCA has no meaning in the EU so it doesn't matter.
2 -> yes, you need to meet both UKCA and CE regulations, afaik, at this moment they do not conflict so it is possible. (note that the UK has many older standards as designated standards which can be a bit if a pain since you technically must meet these old standards and not any newer variants or argue with it has no impact in your riskmanagement for example)
2 -> Try to keep regions together. And tell people in sales/marketing that the 'one box for the entire world' is a fairy tale that is not possible, because of regulations.

 

[DutchMarten]

Correct me if I'm wrong, but I thought that UKCA mark is not yet mandatory and that just recently there was an extension on accepting of just CE mark. However maybe this is only applicable for manufacturers located within EU.

As for the last question of the topic starter: yes it gets confusing and extensive fast and yes in practice this will create confusion however that is the result of a lack of harmonising of labeling requirements by competent authorities and especially if you want to stick with "one label fits all" it is something you will have to live with.

 

[StepPCHen]

Correct me if I'm wrong, but I thought that UKCA mark is not yet mandatory and that just recently there was an extension on accepting of just CE mark. However maybe this is only applicable for manufacturers located within EU.

As for the last question of the topic starter: yes it gets confusing and extensive fast and yes in practice this will create confusion however that is the result of a lack of harmonising of labeling requirements by competent authorities and especially if you want to stick with "one label fits all" it is something you will have to live with.

The extension was applied to non medical device goods. UKCA Marking is still a requirement for Medical Devices (as it stands). Will it still be applicable in the future? Who knows?

 

[DutchMarten]

The extension was applied to non medical device goods. UKCA Marking is still a requirement for Medical Devices (as it stands). Will it still be applicable in the future? Who knows?

CE marking​

We will accept CE marked devices on the Great Britain market until, at the latest, 30 June 2030 depending on device type and classification. This applies to devices that have been CE marked under and fully conform with the following applicable EU legislation:

• Directive 93/42/EEC on medical devices (EU MDD) (for devices with a valid certificate and declaration of conformity that was issued to 26 May 2021)
• Regulation 2017/745 on medical devices (EU MDR)

The government has introduced measures that provide that CE marked medical devices may be placed on the Great Britain market to the following timelines:

• general medical devices, including custom-made devices, compliant with the EU MDR and IVDs compliant with the EU IVDR can be placed on the Great Britain market up until 30 June 2030.

The above timelines will not apply to Class I medical devices and general IVDs under the EU directives, where the conformity assessment under the relevant directive and under the EU MDR or EU IVDR does not involve a notified body. Similarly, they will not include custom-made devices that are compliant with the EU MDD or EU AIMDD.

You can place self-declared CE marked Class I medical devices on the GB market beyond 30 June 2023 if they are

• self-declared against EU MDR requirements (until 30 June 2030), or
• self-declared against MDD requirements before 26 May 2021 where Notified Body involvement in their assessment is not required under MDD but is under EU MDR (until 30 June 2028). This includes upclassified devices and reusable surgical instruments.

Recognition of CE certificates for the Great Britain market​

Currently, under the UK MDR 2002, a CE marked device with a valid certificate is viewed as meeting the UKCA marking requirements whilst the CE marking continues to be recognised in Great Britain - depending on the type of device and legislation it complies with this is until 30 June 2030 at the latest

Regulating medical devices in the UK

See the information above where I am basing this of. Am i understanding this incorrectly? I would seem to me that a CE mark suffices until 2030 and that the absence of a UKCA mark is no problem until then.

 

[StepPCHen]

Regulating medical devices in the UK

See the information above where I am basing this of. Am i understanding this incorrectly? I would seem to me that a CE mark suffices until 2030 and that the absence of a UKCA mark is no problem until then.

That's right, CE Mark will be accepted until 2030 for the UK market

 

[DutchMarten]

That's right, CE Mark will be accepted until 2030 for the UK market

Good to know.