Wellkang Offer Excellent Services At Very Competitive Prices! Are you ready for Brexit? 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 even 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! EEA's EC Rep symbol/logo download & Example of Use of Wellkang's Name/Address For European Authorised Representative/Authorized Representative service By appointing Wellkang as your European Authorised/Authorized Representative (EC Rep), you are allowed to print Wellkang's name and address on your CE-marked Product, Labelling, Packaging, and Sales Literature of your CE-marked product in order to comply with the EU directives and relevant standard such as EN 980:2008. Wellkang's client may use the following Wellkang EC Rep logo & UKRP logo: About CE Marking: Are you ready for Brexit? Wellkang can help under all Brexit scenarios! What is CE marking (CE mark)? The CE marking logo (Free download CE mark logo) Download of the EEA/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"? 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 EEA/EU/EC 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 EEA/EU/EC Authorized Representative Service? 11 benefits by appointing Wellkang as your EEA/EU/EC Authorized Representative? 3 unique benefits offered by Wellkang that are not available from others? Is Wellkang Group part of the U.S. government or EEA authorities? How much does it cost? Competitive Price List! How to contact Wellkang? About Medical Devices Are you ready for Brexit? 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? 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 Click here to contact us for a quotation  | Home | About Us | Contact Us | Copyright & Disclaimer | Privacy | Log-in | Order Now |