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. Are you ready for Brexit impacts? Do you have a Brexit contingency plan? 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. Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical Devices with MHRA in UK & other EEA (EU/EFTA) authorities by world-leading consultancy- Wellkang team based in both UK (England) & EU-27 (Ireland). Wellkang team can help you under all Brexit scenarios! Click here to get FREE Guide Now! 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! 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. The following general rules apply: 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). when attaching the UKCA marking, you take full responsibility for your product’s conformity with the requirements of the relevant legislation. you must only use the UKCA marking to show product conformity with the relevant UK legislation. you must not place any marking or sign that may misconstrue the meaning or form of the UKCA marking to third parties. you must not attach other markings on the product which affect the visibility, legibility or meaning of the UKCA marking. 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: if you reduce or enlarge the size of your marking, the letters UKCA must be in proportion to the version set out below. the UKCA marking is at least 5mm in height - unless a different minimum dimension is specified in the relevant legislation. 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: how the product is designed and manufactured. how the product conforms to the relevant requirements. 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: declare that the product is in conformity with the relevant statutory requirements applicable to the specific product. 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:. meet the essential requirements as set out in the EU legislation. undergo the relevant conformity assessment procedure (including by an EU recognised body, where required). display the relevant EU conformity marking (such as the CE marking). 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 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: Are you ready for Brexit impacts? Wellkang can help under all Brexit scenarios! What is UKCA marking (UK Conformity Assessed marking or UKCA mark)? What is CE marking (CE mark)? The CE marking logo (Free download CE mark logo) Download of the EC Rep symbol/logo CE Marking (CE mark) EU/EC Declaration of Conformity: definition and required content (template) What is a manufacturer? What are the responsibilities of a manufacturer? Is the Own Brand Labeller or Private Labeller considered as the legal Manufacturer? Why is CE marking called "European passport"? CE Marking Conformity Assessment Procedures according to different Modules Does my product need CE Marking for the European Market? How to obtain CE Marking for my product? Where can I find CE marking related publications & guidelines? How to distinguish EU directives? Where can I find CE marking testing labs nearest to my location Why do you need a representative in Europe? Why must the manufactures of medical devices appoint a EU Authorized Representative? Why is the Authorized Representative different from the importer/distributor ? Why choose Wellkang? How can Wellkang help you? What are included in Wellkangs EU Authorized Representative Service? 11 benefits by appointing Wellkang as your EU Authorized Representative? 3 unique benefits offered by Wellkang that are not available from others? Is Wellkang Group part of the U.S. government or EU authorities? How much does it cost? Competitive Price List! How to contact Wellkang? About Medical Devices Are you ready for Brexit impacts? Wellkang can help under all Brexit scenarios! Is my product a Medical Device? How to classify Medical Devices? Medical device CE Marking procedures Steps to obtain CE Marking for your Medical Devices Legal basis for medical devices Why must a medical device manufacture appoint a European Authorized Representative? Examples of EEA/EU/UK CFS/FSC: Certificate of Free Sale (Free Sales Certificate) for Medical Device Why must inform/notify/register with the Competent Authority such as MHRA? Who should apply/register with the Competent Authority such as MHRA? When to inform/notify/register with the Competent Authority such as MHRA? How to inform/notify/register with the Competent Authority such as MHRA? Cost and fees for the registration of medical devices with MHRA Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA for In Vitro Diagnostic Medical Device (IVD) Examples of Registration Confirmation Letter issued by UK Competent Authority MHRA for Medical Device (MD) Role of the European Authorised Representative (Authorized Representative) in the MHRA registration How to change the registered details with MHRA? FAQs: Frequently Asked Questions about registration with Competent Authorities in Europe Register/Notify your Medical Device (MD) & In Vitro Diagnostic Medical Device (IVD) with MHRA- UK Medicines and Healthcare products Regulatory Agency now! Conformity Modules applicable for CE marking of MD and IVD Medical Devices All Certificates Notified Bodies can issue under the 3 medical devices directives Class I (including Is & Im) medical devices CE Marking procedures Class IIa medical devices CE Marking procedures Class IIb medical devices CE Marking procedures Class III medical devices CE Marking procedures IVD-In Vitro Diagnostic medical devices CE Marking procedures AIMD-Active Implantable medical devices CE Marking procedures  | Home | About Us | Contact Us | Copyright & Disclaimer | Privacy | Log-in | Order Now |