Search results for 'labelling medical device Italy':
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italy introduces new rules regarding medical devices and in vitro ...
On September 28, 2022, Legislative Decrees no. 137 and no. 138 of August 5, 2022 entered into force, adapting Italy’s national regulatory framework to the European Union’s Regulations (EU) no. 2017/745 and no. 2017/746 regarding medical devices and in vitro diagnostic medical devices respectively. This marks an important step forward in ensuring a higher level of safety of medical devices ...
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. As of Oct. 16, 2022, the new rules of the March 21, 2022 Decree “ Establishment of the national device-vigilance ...
white paper medical devices labelling: instructions for use - thema med2 / 13 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. It is mandatory and fundamental to apply the requirements for the labelling of Medical Devices as the information on the product label helps the user to identify ...
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a guide to enter your medical device in italy | regdeskA Guide to Enter Your Medical Device in Italy. May 24, 2019. Medical devices in Italy are subject to the same regulations as all countries in the European Union (EU) which were implemented in 2017. Here, you can find out more information on the EU MDR and IVDR regulation.
medical device registration in italy - thema medDocumentation and labelling must be provided in Italian. Useful information. The site of the General Directorate of Medical Devices and the Pharmaceutical Service of the Ministry of Health is constantly updated. Like all the Countries of the European Union, Italy will also adopt the New Regulation (EU) 2017/745 on Medical Devices.
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 ...
italy: new guidance on translation of labels and repackaging of medical ...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.