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Changes compared to the Medical Device Directive include changes in device classification and device scope, stricter oversight of manufacturers by notified bodies, introduction of the "Person Responsible for Regulatory Compliance" (PRRC) and of the economic operator concept, the requirement of Unique Device Identification marking for devices, EUDAMED registration (see below), UDI requirements ...
According to the 2011 budget, the Greek healthcare system was allocated 6.1 billion euro, or 2.8% of GDP. [1] In a 2000 report by the World Health Organization, the Greek healthcare system was ranked 14th worldwide in the overall assessment, above other countries such as Germany (25) and the United Kingdom (18), while ranking 11th at level of ...
register or a list of a specified type of regulated entities or activities — contains entries on companies officially authorized to perform a specified type of business, where prior obtaining of a permit, a license, a concession, or registration on such a list or register is a prerequisite required by law. Depending on situation, regulation ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
The GRNET backbone interconnects more than 100 institutions including all universities and technological institutions, research centers, public hospitals, museums, and libraries, as well as the Greek School Network. GRNET is present in global networking for research and education, representing Greece in GÉANT.
Greece is a country in southeastern Europe. Greece is developed country with an advanced high-income economy, a high quality of life, and a very high standard of living.A founding member of the United Nations, Greece was the tenth member to join the European Communities (precursor to the European Union) and has been part of the Eurozone since 2001.
At the same time the NB-MED (European Forum of Notified Bodies Medical Devices) coordination revised their code of conduct due to criticism. [7] [15] In late 2013 and early 2014, a French court ordered (and later upheld its decision) that notified body TÜV Rheinland pay restitution to those affected by the PIP scandal. [16]
The Medical Device Directive—Council Directive 93/42/EEC of 14 June 1993 concerning medical devices—is intended to harmonise the laws relating to medical devices within the European Union. The MD Directive is a 'New Approach' Directive and consequently in order for a manufacturer to legally place a medical device on the European market the ...