MEDICAL DEVICES – POST MARKET SURVEILLANCE: THE INTRODUCTION OF PERIODIC SAFETY UPDATE REPORT

As part of an ever-increasing improvement in post-marketing surveillance activities for medical devices, the new EU regulation 2017/745 introduces the…

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MEDICAL DEVICES – IMPACT OF THE NEW REGULATION ON MEDICAL DEVICES CONTAINING SUBSTANCES

Currently, many over-the-counter medical devices are substances or combinations of substances. Medical devices containing substances are the medical devices that…

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CLINICAL TRIAL – ITALY TOWARDS THE IMPLEMENTATION OF THE NEW EU REGULATION 536/2014

In view of the new European legislation (EU Regulation 536/2014) about the clinical trial, the Law No. 3 of 11…

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REGULATORY AFFAIRS – ASSENT-BY-DEFAULT PROCEDURE UPDATE

With the new disposition DG/512/2019 of 12 March 2019, AIFA has updated the application of the assent-by-default procedure, in force…

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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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CLINICAL TRIALS – 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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