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
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Who should apply/register with the Competent Authority?
The EEA Competent Authorities usually charge fees for the registration/notification.
- For General Medical Devices:
You must register with the Competent Authority in an EEA Member State in which you have your registered place of business if you:
If you do not have a registered place of business in the EEA Member State you must designate an authorised representative established in the EEA to act on your behalf.
- manufacture class I or custom made devices and place them on the market under your own name, or trading name(s);
- fully refurbish class I devices, or label one or more ready made devices, with a view to placing them on the market under your own name;
- place devices bearing the CE marking on the market, under your own name in a system or a procedure pack within their intended purposes and within the limits of uses specified by their original manufacturers;
- sterilise, for the purpose of placing on the market under your own name, systems or procedure packs or other CE marked medical devices designed by the manufacturer to be sterilised before use;
- are the authorised representative of a manufacturer who does not have a registered place of business in the EEA.
Custom Made Devices mean devices manufactured in accordance with a professionalís written prescription for the sole
use of a particular patient and are not adapted from mass produced items.
- For In Vitro Diagnostic Medical Devices (IVDs):
You must register with one Competent Authority in a Member State in which you have your registered place of business if you:
If you do not have a registered place of business in a Member State and you wish to place IVDs on the European market then you must designate a person established in the Community to act on your behalf as your Authorised Representative.
- manufacture in vitro diagnostic medical devices (IVDs) and place them on the market under your own name, or trading name(s);
- manufacture IVDs for performance evaluation and make them available under your own name, or trading name(s);
- are the authorised representative of a manufacturer who does not have a registered place of business in the Community.
- For Active Implantable Medical Devices
Directive 2007/47/EC amends the Active Implantable Medical Devices Directive 90/385/EC and came into force on 21 December 2008. One change to the directive especially affects persons responsible for placing and putting into service custom made active implantable medical device(s) on the EU market.
Article 1.11 of Directive 2007/47/EC amends Article 10 of Directive 90/385/EC to include a requirement for manufacturers of custom made active implantable medical devices to provide the Competent Authority of the member state in which they have their registered place of business details of their address, a description of the device(s) concerned, the product labelling and the instructions for use.
The revisions to the directives have been transposed into UK law, under the Medical Devices (Amendment) Regulations 2008, and came into force on 21 December 2008. However the regulations only become mandatory on 21 March 2010.
During this transitional period manufacturers of custom made active implantable medical devices or their designated authorised representatives are not required to register their details with the UK Competent Authority MHRA, however they may wish to and can do so by completing the RG2 form. In addition to the completed form, manufacturers or their authorised representatives must also provide the competent authority with a copy of the device label and the Instructions For Use (IFU) that will accompany the device.
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