Contact Us
Why Must? Who Should? When should I start? How to proceed? Frequently Asked Questions (FAQs) Cost & Fees
Why must I? 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!

Why must I inform/notify/register with the Competent Authority?

Legal basis: All the three EU directives concerning medical devices, i.e., the Medical Devices Directive (MDD 93/42/EEC amended by 2007/47/EC)*, In Vitro Diagnostic Device Directive (IVDD 98/79/EC)**, and Active Implantable Medical Devices Directive (AIMDD 90/385/EC) *** require manufacturers or, their authorised representatives or others placing medical device(s) on the EEA market, to provide certain information to the Competent Authorities in the EEA Member State where they have a registered place of business.
          * Article 14 of Directive MDD 93/42/EEC amended by 2007/47/EC;
        ** Article 10 of Directive IVDD 98/79/EC;
      *** Article 10 of Directive AIMDD 90/385/EC.

These requirements have been transposed into national laws of the EEA Member States. In UK, the national law is Medical Device Regulations 2002: Regulations 19 and 44 registration of persons placing general medical devices and/or in vitro diagnostic medical devices on the market.

After the receipt of the notification/registration, the Competent Authorities shall process the data and inform the Commission of the European Communities and the other States Party to the Agreement on the European Economic Area, upon request.

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 |