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The EUropean DAtabase on MEdical Devices (EUDAMED) is a database to collect and publish information on medical devices and in-vitro-diagnostica. EUDAMED has six modules: Actors registration; UDI/Devices registration; Notified Bodies and Certificates; Clinical Investigations and performance studies; Vigilance and post-market surveillance; Market ...
Device History Record (DHR) Design History File (DHF) The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of medical device to establish a Technical file, similar to a device master record. The EU medical device regulation requires a manufacturer of a medical device to maintain a Technical documentation.
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.
As a non-EU manufacturer of medical devices, the manufacturer's legal representative must appoint a "responsible individual person or company" to register their product with the Italian database. The official form needed is available here: This "responsible individual person or company" will communicate with the Italian Ministry of Health on ...
A design history file is a compilation of documentation that describes the design history of a finished medical device.The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient.
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 ...
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Certification Review Item (CRI) is a document describing an item that requires disposition prior to the issuance of Type Certificate (TC), change to TC approval or Supplemental Type Certificate (STC) by European Aviation Safety Agency (EASA).
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