REGULATORY AFFAIRS – MANDATORY USE OF COMMON EUROPEAN SUBMISSION PORTAL FOR MUTUAL RECOGNITION PROCEDURE/DECENTRALIZED PROCEDURE

According to the eSubmission Roadmap, from July 1st 2019, the use of the Common European Submission Portal (CESP) has become…

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REGULATORY AFFAIRS – AIFA CLARIFICATIONS ON THE SUBMISSION OF MARKETING AUTHORIZATION TRANSFER APPLICATIONS OF NATIONAL MUTUAL RECOGNITION PROCEDURE/DECENTRALIZED PROCDURE FOR MEDICINAL PRODUCTS

AIFA clarifications on the submission of Marketing Authorization Transfer applications of national/MRP/DCP medicinal products With a recently published notice, on…

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MEDICAL DEVICES – EXTENSION OF THE APPLICATION FIELD AND MEDICAL DEVICES WITH NON-MEDICAL PURPOSES (Annex XVI)

The new European Regulation 2017/745 will bring many innovations. One of these concerns the extension of the Regulation application field….

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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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