Search results for 'labelling medical device Italy':
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italy introduces new rules regarding medical devices and in vitro ...
The prohibition of advertising to the public of custom-made devices, of devices for which the use requires the assistance of a doctor or a health professional (either by law or by the manufacturer’s guidelines), and of devices requiring a doctor’s prescription; The need for authorization by the Ministry of Health for all other cases.
a guide to enter your medical device in italy - regdeskIn Italy, medical devices are regulated by the Ministry of Health Directorate General for Medicines and Medical Devices using the National Health Information System (NSIS). Overview Contents Overview Registration Market overview The EU harmonized standards on medical devices apply to all European Union member states, and Italy is no exception.
italy: new guidance on translation of labels and repackaging of medical ...In brief. On 18 August 2021, the Medical Device Coordination Group (MDCG), composed of representatives of all Member States and chaired by a representative of the European Commission, published the guidance on procedures for the translation of labels and instructions for use, as well as the repackaging of medical devices. The guidance is ...
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registering medical devices in the national database - salute.gov.itThe medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the procedures foreseen by the MDR until the European Database on Medical Devices - Eudamed - is fully ...
the import of medical devices in italy - di renzo regulatory affairsThe labelling and the instructions for use must be necessarily written in Italian in order to import the medical devices in Italy. The procedure is the same for all the classes of medical devices; if the medical devices were object of procedures of conformity assessment involving a Notified Body, the relevant certificate of conformity must be attached to the import request.
italy’s new device-vigilance network: how to prepare for itItaly has recently instituted substantial changes in national regulations on medical device vigilance in order to align our procedures with European Regulations 2017/475 for medical devices and 2017/476 for in vitro diagnostics.
white paper medical devices labelling: instructions for use - thema medINTRODUCTION The White Paper “Medical Devices Labelling: instructions for use” explains from a regulatory point of view what are the labelling requirements of Medical Devices according to the MDR (EU) 2017/745 Regulation.