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Sonalleve MR-HIFU is a medical system developed by Philips Healthcare for the treatment of uterine fibroids without surgery. The system uses non-invasive high-intensity focused ultrasound (HIFU) guided by magnetic resonance (MR), hence the acronym MR-HIFU. The procedure involves volumetric heating of fibroids with real-time feedback. [1]
There are mechanisms in place to ensure that the CE marking is put on products correctly. Controlling products bearing CE marking is the responsibility of public authorities in member states, in cooperation with the European Commission. Citizens may contact national market surveillance authorities if the misuse of the CE marking is suspected or ...
The CE mark found on the back of many electronic devices does not mean that the product has obtained type approval in the European Union. The CE mark is the manufacturer's declaration that the system/assembly meets the minimum safety requirements of all the directives (laws) applicable to it, and of itself, does not signify any third party ...
CE Mark. A notified body, in the European Union, is an organisation that has been designated by a member state to assess the conformity of certain products, before being placed on the EU market, with the applicable essential technical requirements. These essential requirements are publicised in European directives or regulations.
The Unique Device Identification (UDI) System is intended to assign a unique identifier to medical devices within the United States, Europe, China, South Korea, Saudi Arabia and Taiwan. [1] It was signed into law in the US on September 27, 2007, as part of the Food and Drug Administration Amendments Act (Section 226) of 2007 .
As clarified in the Medical Devices Directive — Directive 93/42/EEC [4] — it is required that alongside the CE mark all products must also have an Authorised Representative. As stated in this amendment, an Authorised Representative should serve as a contact point with the EU member states competent authorities.
The main difference between GS and CE mark is that the compliance with the European safety requirements has been tested and certified by a state-approved independent body. [1] [2] [3] CE marking, in contrast, is issued for the signing of a declaration that the product is in compliance with European legislation. The GS mark is based on the ...
SIR-Spheres were CE-marked as a medical device in 2002, for treating advanced inoperable liver tumors, and Theraspheres in 2014, for treating hepatic neoplasia. [37] QuiremSpheres (PLLA 166 Ho microspheres) received their CE mark in April 2015 for treating unresectable liver tumors and are currently only available for the European market.