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.
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.
a guide to enter your medical device in italy | regdesk
In 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 Registration Market overview The EU harmonized standards on medical devices apply to all European Union member states, and Italy is no exception.
white paper medical devices labelling: instructions for use - thema med
INTRODUCTION 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.
registrazione di un dispositivo medico in italia - thema med
La documentazione e il labelling devono essere forniti in italiano. Informazioni utili. Il sito della Direzione Generale dei Dispositivi Medici e del servizio farmaceutico del Ministero della Salute è costantemente aggiornato. Come tutti i Paesi dell’Unione Europea, anche l’Italia adotterà il Nuovo Regolamento (UE) 2017/745 sui ...
medical devices | european medicines agency
Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices. The In Vitro Diagnostic Devices Regulation applies since 26 May 2022. It repeals Directive 98/79/EC of the European Parliament and of ...
italy’s new device-vigilance network: how to prepare for it
Italy 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.