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Wellkang is a registered EU Authorised Representative (EC Rep) in the European Commission's EU medical device database EUDAMED under a unique Single Registration Number (SRN): XI-AR-000001836 for the markets of EEA/EU27 & Northern Ireland.

Wellkang is also a registered UK Responsible Person (UKRP) in the UK MHRA medical device database for the market of Great Britain: England, Wales & Scotland, after 1 Jan 2021, which is no longer part of the EU single market after Brexit.

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You may need either an EU/EC European authorized representative based in EU-27 countries or a UK Authorised Representative (so-called "UK Responsible Person") based in UK, or may need both EU & UK representatives, depending on different brexit scenarios.

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After 29 March 2019 if there’s no Brexit deal between UK & EU, i.e. under a cliff-edge hard Brexit, you may need to appoint both an EU (EEA/EC) Authorized Representative (EC Rep), based in EU27 or EEA, and a UK Authorised Representative (UK Rep, so-called "UK Responsible Person"), based in the United Kingdom, if you place products on both UK or EU27/EEA markets! You MUST have a Brexit contingency plan if you place products on either UK or EU27/EEA markets! Wellkang team can help you under all Brexit scenarios! Click here to get FREE Guide Now!

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The UKCA (UK Conformity Assessed) marking, as shown above, is the new UK product marking that will be used, subject to parliamentary approval, for certain goods being placed on the UK market if the UK leaves the EU without a Brexit deal.

If the UK leaves the EU without a deal you will still, in the majority of cases, be able to use the CE marking to demonstrate compliance with the legal requirements and to sell products on the UK market after 29 March 2019. However, in some cases you will need to apply the new UKCA marking to products being sold in the UK.

When to use the UKCA marking

Most, but not all, products which are currently covered by the CE marking will fall within scope of the new UKCA marking.

The rules around using the new UKCA marking will mirror those which currently apply for the application of the CE marking.

In most cases you will still be able to use the CE marking for products being placed on the UK market. However, if your products require third party assessment of conformity, and if this has been carried out by a UK conformity assessment body, you will have to apply the new UKCA marking after 29 March 2019 (where required by legislation). This will not be the case if the certificate of conformity has been transferred to an EU-recognised body (in which case the CE marking would apply).

If you currently rely solely on a self-declaration of conformity for the CE marking you will also be able to use the UKCA marking based on self-declaration, for those products within scope of the marking.

The UKCA marking will not be recognised on the EU market, and products currently requiring a CE marking will continue to require a CE marking for sale in the EU.

Using the UKCA marking

Placing the UKCA marking

You should attach the UKCA marking to the product itself, but in some circumstances it may be placed on the packaging, in manuals or on other supporting literature. Rules covering the use of the UKCA markings vary depending on the specific legislation that applies to the product.

    The following general rules apply:

  1. UKCA markings must only be placed on a product by you as the manufacturer or your authorised representative (where allowed for in the relevant legislation).
  2. when attaching the UKCA marking, you take full responsibility for your product’s conformity with the requirements of the relevant legislation.
  3. you must only use the UKCA marking to show product conformity with the relevant UK legislation.
  4. you must not place any marking or sign that may misconstrue the meaning or form of the UKCA marking to third parties.
  5. you must not attach other markings on the product which affect the visibility, legibility or meaning of the UKCA marking.
  6. the UKCA marking cannot be placed on products unless there is a specific requirement to do so in the legislation.

Rules for using the UKCA image

    Depending on the specifics of the legislation that covers your product, you must make sure that:

  1. if you reduce or enlarge the size of your marking, the letters UKCA must be in proportion to the version set out below.
  2. the UKCA marking is at least 5mm in height - unless a different minimum dimension is specified in the relevant legislation.
  3. the UKCA marking is easily visible, legible and permanent (meaning indelible).

Technical documentation

You, or your UK authorised representative (where allowed for in the relevant legislation), must keep documentation to demonstrate that your product conforms with the statutory requirements. This information can be requested at any time by market surveillance or enforcement authorities to check that your product conforms with the statutory requirements. This can be up to a maximum of 10 years after the product is placed on the market.

    The information you must keep will vary depending on the specific legislation relevant to your product. You must keep general records of:

  1. how the product is designed and manufactured.
  2. how the product conforms to the relevant requirements.
  3. the addresses of the manufacturer and any storage facilities.
You should keep the information in the form of a technical file which can be supplied if requested by a market surveillance authority.

UK Declaration of Conformity (UK DoC)

    The UK Declaration of Conformity is a document which must accompany most products lawfully bearing a UKCA marking. In the document you as the manufacturer, or your authorised representative (where allowed for in the relevant legislation), should:
  1. declare that the product is in conformity with the relevant statutory requirements applicable to the specific product.
  2. make sure the document has the name and address of the manufacturer (or your authorised representative) together with information about the product and the conformity assessment body (where relevant).

Using the CE marking

Continued use of the CE marking in the UK

You will not need to do anything for goods that are sold on the UK market before 29 March 2019. These goods can continue to circulate in the UK as they do now without any changes to the marking requirements.

After 29 March 2019 you will still be able to sell goods which have been made and assessed against EU regulatory requirements and then CE marked on the UK market. This is intended to be for a time-limited period.

    To place CE marked goods on the UK market after 29 March 2019, you will need to ensure that these goods:.
  1. meet the essential requirements as set out in the EU legislation.
  2. undergo the relevant conformity assessment procedure (including by an EU recognised body, where required).
  3. display the relevant EU conformity marking (such as the CE marking).
  4. are accompanied by technical documentation or other records and an EU declaration or attestation of conformity (in English).
You will still be able to use CE marking based on self-declaration of conformity, when placing products on both the UK and EU markets, during this time-limited period.

For more information, please visit our website at, or you can click here now for a quotation.

* The European Economic Area (EEA):

The EEA includes EU countries and also Iceland, Liechtenstein and Norway. It allows them to be part of the EEA single market.

Switzerland is a member of EFTA, but neither an EU nor EEA member. It however is still part of the single market.

About CE Marking:
About Medical Devices

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