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As of of Council Directive 93/42/EEC as amended by Directive 2007/47/EC: Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a in the European Economical Area (EEA).
For devices referred to in the first subparagraph of paragraph 1, the authorised representative shall inform the competent authority of the EEA member State in which he has his registered place of business of the details referred to in paragraph 1.
Both the Medical Devices Directive (93/42/EEC) and In Vitro Diagnostic Medical Device Directive (98/79/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.
These requirements have been transposed into national laws of the EEA Member States.
All Class Is, Im, IIa, IIb and III medical devices require the intervention of third party: the so-called Notified Body.
This includes, for instance, devices activated by means of pressure, unless this effect is achieved by energy resulting from the patients body.
The definition implies that the function of the device involves using the source of power to perform useful work.
Read more: Class I (including Is & Im) medical devices CE Marking procedures For more information about classification rules, please visit Guidelines for Classification of Medical Devices.
The IVD Directive (98/79/EC) groups IVDs into four categories.