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.
After 29 March 2019 if thereís 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!
Do you export to UK? Let Wellkang Group help you!
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.
Rules for using the UKCA image
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.
UK Declaration of Conformity (UK DoC)
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.
For more information, please visit our website at www.UKCA-marking.com, 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