Contact Us
Why Must? Who Should? When should I start? How to proceed? Frequently Asked Questions (FAQs) Cost & Fees
When should I start? Let Wellkang be your EU/EC European Authorized Representative! Click here to learn more/continue ...

Register your Medical Devices (MDs & IVDs) in Europe with Competent Authority MHRA- UK Medicines and Healthcare products Regulatory Agency.

As of 21 March 2010, a Single EU/EC European Authorised/Authorized Representative must be designated by a non-EU manufacturer of medical devices as required by directive 2007/47/EC, are you ready?
Register/Notify your MD-Medical Devices & IVD-In Vitro Diagnostic Medical
Devices with MHRA & other EU/EFTA authorities by world-leading CE Marking
Specialists based in London/UK. Click here to get FREE Guide Now!

When to inform/notify/register with the Competent Authority?

  • For General Medical Devices:

    You must inform the Competent Authority when you first apply the CE marking to your class I device(s). If you have a number of models and the CE marking procedure is being introduced over a period, you may if you wish, inform the Competent Authority of all devices when informing of the first CE marking.

    Manufacturers of custom-made devices, systems or procedure packs, and sterilisation companies, should register no later than the first time they claim compliance with the Directive.

  • For In Vitro Diagnostic Medical Devices (IVDs):

    For In Vitro Diagnostic Medical Devices there is a transitional period until 7 December 2003 in respect of a device placed on the market and a transitional period until 7 December 2005 in respect of a device put into service, during which a manufacturer can choose either to follow existing national regulations to apply the CE mark. You must inform the Competent Authority when you first apply the CE marking to your IVDs.

Go to Top


Go to Top

FAQ/Q&A: Questions and Answers about CE Marking of Medical Devices
About CE Marking:

 Home | About Us | Contact Us | Copyright & Disclaimer | Privacy | Log-in | Order Now |