How To Prepare For New UKCA Mark on 1/1/2023 (March 10,2022)

 

1. Question:

Does the EU accept the UKCA mark next to the CE mark as well on the same product?

Answer:

Dual marking is acceptable for both the EU and the UK, meaning the CE and UKCA marking can both be on a good. They mustn't obscure each other, and you will need to have separate certificates for each marking.

2. Question:

What about spare parts and components to include in complex machines or prototypes or spare parts or repair products?

Answer:

Generally, it depends on the regulation for spare parts and you must check the specific product regulation for your product. As a rule of thumb, if the product is saleable as a product in and of itself so taken. Taking the Example of a car radio. It's both a part of a car, but it's also a product in its own right. It will need the UKCA marking. But it does depend on the legislation which must be checked for each product.

3. Question:

Where can they find the information on changes on product standards or regulation, potentially in the future, where can they all find?

Answer:

So there's a number of sites, but the main one will be the A-Z industry guidance (for individual product sectors): https://www.gov.uk/guidance/product-safety-for-businesses-a-to-z-of-industry-guidance

4. Question:

If we will pull products on the GP and Northern Ireland markets, which are regarding 2642 slash EU with declaration of incorporation and X21B without CD marking.

Answer:

So without knowing exactly the product type under that regulation, I can only answer in general terms. So to place a product on those markets without the CE marking, you'd need to have the UK CA marking.

For Great Britain and then for Northern Ireland, you'd have to have the UK and I marking plus the CE marking or the CE plus the UKCA marking.

You could also replace that the second one with the CE marking it depends a little bit, but in most cases products will probably end up having the CE marking which will cover the EU and Northern Ireland and the UK CA marking which covers GB and but obviously the UK line marking is there if you don't have the seed marking.

5. Question:

For which products does the UK CA apply to? Is this only applicable for consumer goods? Or would it also be applicable for steel structures and equipment installed on these structures?

Answer:

With regards to the steel structures. Ian 1090 comes to mind, but this. This is a CPR. Question with CPR I mean Construction, products, regulation and the Construction Products Regulation. CPR is very much affected by UK, so you would really need UK to keep exporting to the UK for this.

6. Question:

Is there a clear overview about the CE&U CCA differences for Class one medical devices under MDR and the question MDR 2017?

Answer:

We have got specific guidance on medical devices because it's obviously owned by the Department of Health here is the link: Gov.uk medical devices guidance https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk

7. Question:

We mainly produce inverter which converts directly current DC to alternating current AC. We also deliver our goods to the UK. I would like to ask how the manufacturer or the UK Authorized representative. In our case, a subsidiary of Asthma has to give information about itself like name, address and phone number for a Surface hold line to the customer on the product itself, on the Declaration of conformity and or on the technical documentation.

Answer:

For compliance questions within the UK itself and your authorized representative, the way you are describing your authorized representative is actually quite complete. So name, address and phone number or service hold line or an email address.

In terms of labelling the important point is that some point of contact and responsibility must exist in the UK if the manufacturer is outside of the UK market. This must be a legal representative whose details are on the product and that can be either importer or it could be the authorized representative and those details must reach the end user and generally the specific guidance for each product type will tell you if those details are on the product or if there are allowances for it to be on the packaging.

8. Question:

About the product you will only use in the UK, for example, like personal protective equipment. So in European company will use their own PPE with CE marking for their own employees temporarily working in the UK. For example, an offshore project is this.

Answer:

The answer depends on what the territorial scope of the PPE regulations. The company will need their own legal advice on this. In principle just moving the goods into GB without making them available does not constitute placing on the market. However, the answer will depend on where within the UK Continental Shelf they are going and the territorial scope of relevant regulations in light of this.

9. Question:

Can single components used in an overall installation which is used UK CA marked still BCE marked only?

Answer (BSI):

Yes, I've had this question a lot of times as well, because a lot of people are exporting components to the UK market and then of course they'll be wanting to know well, we're sending out those components and they will be installed.

Let's say a larger machine, it will still need UK CA marking.

We also say keep in mind that once the machine is assembled, it could become something else, so the components become part of a whole and the whole would need to be certified. And that the whole would be certified under UK CA in that case. And this of course depends on the regulation that it falls under but a component being a part of a larger machine, without being able to stand on itself that would just be part of the new total product. It would be and under UK CA.

 

10. Question: Is a list available for all products which require UK markings, it also goes for dairy products fit for human consumption?

Answer:

So in terms of dairy products fit for consumption, they wouldn't need the UKCA marking. There might be other requirements which they have to fall under, but that's obviously kind of food related.

 

 

Query on the movement of PPE goods purchases in Europe and used (by the same owner) in the UK – is CE marking sufficient?

The answer depends on what the territorial scope of the PPE regulations. The company will need their own legal advice on this. In principle just moving the goods into GB without making them available does not constitute placing on the market. However, the answer will depend on where within the UK Continental Shelf they are going and the territorial scope of relevant regulations in light of this.

General supporting links from the UK government

You can find more details hon specific information on spares, components and leasing goods under 'Further Guidance' on this page https://www.gov.uk/guidance/placing-manufactured-goods-on-the-market-in-great-britain#further-guidance

The links shared below are also relevant to businesses as they provide guidance and online events on the UKCA marking. Please do share these widely with your network and do let us know should you receive questions on these. 

 

UK Government Information and support on the UKCA transition, 1 January 2023 deadline . 

Guidance available for businesses: 

• ·        Guidanceon using the UKCA marking  
• ·        Guidanceon using the UKNI marking  
• ·        Guidance on placing goodson the market in Great Britain 
• ·        Guidance on placing goodson the market in Northern Ireland 
• ·        A-Z of industry guidanceto understand requirements for product types. 

Challenges outlined by Phillips

Medical devices, IVD’s and SPP’s:

• Timing of publication of regulatory framework for medical devices vs deadline 30 June 2023 for UKCA marking
  • The UK Government has undertaken consultation on this issue and will be publishing further guidance on this in the coming months.
• Additional labelling requirements for UK (cost and sustainability impact)
  • The UK Office for Product Safety and Standards has undertaken a consultation as part of the product safety review. We will use the information supplied, alongside wider evidence and research, to shape policy proposals for the UK’s product safety framework, to ensure it is future facing and optimised for UK consumers, businesses, and enforcement agencies.
  • A labelling easement enabling the UKCA marking to be attached to the packaging or on the accompanying documents until 1 January 2024 is in place to support businesses.
• UK Economic Operators requirements (including labelling)

Importers must indicate their details (name, registered trade name or registered trademark, and postal address – usually a number, street, and postcode) on the good. The legislation sometimes permits placing these details on packaging, or placing them on accompanying documentation, as an alternative to affixing them to goods themselves To smooth the transition, until 31 December 2022, importer details can be affixed to a label attached to the good or on accompanying documentation if goods are from the EU (and the EEA and Switzerland, where EU legislation is implemented in those countries).

• Availability/capacity of UK Approved Bodies
  • To further support businesses adapt to the new goods regime, we introduced legislation that allows CE-marked goods to continue to be placed on the GB market (England, Scotland, and Wales) for a further year until 1 January 2023.
  • Throughout 2022, we will continue to engage actively with the industry and support their preparations for the new rules. Meanwhile, we welcome feedback, comments, and suggestions from the industry on the challenges they are facing, so we can support them best. Further work including subcontracting, publishing etc

Non-medical device products and spare parts/components:

• Additional labelling requirements for UK (cost and sustainability impact)
  • The UK Office for Product Safety and Standards has undertaken a consultation as part of the product safety review. We will use the information supplied, alongside wider evidence and research, to shape policy proposals for the UK’s product safety framework, to ensure it is future facing and optimised for UK consumers, businesses, and enforcement agencies.
  • A labelling easement enabling the UKCA marking to be attached to the packaging or on the accompanying documents until 1 January 2024 is in place to support businesses.
  • Importers must indicate their details (name, registered trade name or registered trademark, and postal address – usually a number, street, and postcode) on the good. The legislation sometimes permits placing these details on packaging, or placing them on accompanying documentation, as an alternative to affixing them to goods themselves To smooth the transition, until 31 December 2022, importer details can be affixed to a label attached to the good or on accompanying documentation if goods are from the EU (and the EEA and Switzerland, where EU legislation is implemented in those countries).

• 3^rd party supplied non-medical products and compliance to UK regulations from their side
  • Further guidance on medical devices will be issued across 2022 to support businesses.

• Identification of all CE marked spare parts/components and converting them to UKCA mark.
  • BEIS are aware of industry concerns around whether spares will require the UKCA marking and we recently finished a survey with industry to hear more about concerns. Officials will continue to engage businesses on this issue.
• Spare parts/components –no longer manufactured, refurbished etc. How to comply with UKCA mark?
  • BEIS are aware of industry concerns around whether spares will require the UKCA marking and we recently finished a survey with industry to hear more about concerns. Officials will continue to engage businesses on this issue.

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