Who should apply/register with the Competent Authority?
You must register with one Competent Authority in a Member State in which you have your registered place of business if you: • 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. 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.
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: • 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 b
