MEDICAL DEVICES– THE CND NOMENCLATURE: The new european medical device nomenclature

According to Article 26 of Regulation 745/2017 on medical devices, a European Medical Device Nomenclature will be available to support…

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MEDICAL DEVICE – European Regulation 2017/745 – Clinical Evaluation: focus on class III medical devices

Among the several main innovations news introduced with European Regulation 2017/745 regarding clinical evaluation topic, it is important not to…

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MEDICAL DEVICES – European Regulation 2017/745 – New rules for the clinical evaluation – The Summary of Safety and Clinical performance

The new European Regulation 2017/745 will introduce a new clinical document: the “summary of safety and clinical performance”. This document…

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CALL AIFA 2018 FOR INDEPENDENT RESEARCH ON MEDICINAL PRODUCTS

The Italian Medicines Agency (AIFA) has recently published a call for independent research focused on three thematic areas considered of…

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SCIENTIFIC SERVICE IN ITALY: FROM THE PAST TO THE FUTURE

Since 1  July  1993 with the Legislative decree 30 December 1992, n. 541 and after its abolition following the entry…

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IMPACTS AND NEWS OF THE FINANCIAL LAW 2019

Within the publications of the annual Financial Law, some new depositions have been set for the healthcare system and the…

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EUROPEAN REGULATION 2017/745 – NEW DEFINITION OF INCIDENT AND UPDATES ON VIGILANCE AND POST-MARKET SURVEILLANCE ACTIVITIES

The new European Regulation 2017/745 on medical devices will introduce new activities and a new approach in the management of…

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THE MAIN INNOVATIONS OF THE EUROPEAN REGULATION 745/2017

In about one year the new European regulation on medical devices, European Regulation 745/2017, will be reality and the new…

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EUROPEAN REGULATION 2017/745 – Clinical evaluation: new requirements for equivalence demonstration

The European regulation 2017/745, that will entry into force in May 2020, introduces several new elements with an impact on…

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“Pharma disclosure”: EFPIA’s Code on Transfers of Value

Starting from 2016, European Federation of Pharmaceutical Industries and Associations (EFPIA) member companies made public the details of payments and…

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