MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – NEW PROCEDURE FOR THE AUTHORIZATION OF USE IN DEROGATION OF THE FACIAL PROTECTIVE DEVICE WITH A MEDICAL INTENDED PURPOSE

In order to better manage the emergency due to the COVID-19 and ensure the supply of protective device against the…

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CLINICAL TRIALS – “DECRETO CURA ITALIA” (LEGISLATIVE DECREE N.18 OF 17/03/2020): CLINICAL TRIALS AND COMPASSIONATE USES FOR THE TREATMENT OF PATIENTS AFFECTED BY COVID-19

In the article 17 of the Legislative decree n.18 published on 17/03/2020, the Italian government provides indications on the management…

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MARKET ACCESS – TRANSITIONAL MEASURES RELATING TO THE EXTENSION OF AIFA MONITORING REGISTERS AND THERAPEUTIC PLANS DURING COVID-19 EMERGENCY

Considering the current epidemiological emergency from Covid-19, the Italian Medicines Agency AIFA has communicated some transitional provisions related to monitoring…

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CLINICAL TRIALS – MANAGEMENT IN ITALY DURING THE COVID-19 EMERGENCY

The Italian Medicines Agency (AIFA) has provided the following specific indications for the management of clinical trials in Italy during…

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MEDICAL DEVICES – MDR: UPDATES ON DESIGNATION STATUS OF NOTIFIED BODIES

Although experts focus mainly of the impact of the Regulation (EU) 2017/745 (MDR) on the activities of companies involved in…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – NEW REQUIREMENTS FOR MEDICAL DEVICE PRE-MARKET CLINICAL TRIALS AUTHORIZATION

The Directive 93/42/EEC did not regulate in depth the clinical investigations with medical devices and most was delegated to the…

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REGULATORY AFFAIRS – NOTIFICATION OF SHORTAGES OF MEDICINAL PRODUCTS

According to the definition reported in the Guidance on detection and notification of shortages of medicinal products for Marketing Authorisation…

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REGULATORY AFFAIRS – ACCESS AIFA FRONT END PORTAL – “TRACCIABILITÀ DEL FARMACO – TITOLARI AIC”

With Ministerial Decree of 11th May, 2018 published in the IOJ n.147 dated 27th June, 2018, some aspects linked to…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – CHANGE IN THE QUALITY SYSYTEM FOR COMPLIANCE WITH THE REGULATION

All the manufacturers of medical devices have set up a quality system in order to be in compliance with the…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – THE IMPACT OF THE II CORRIGENDUM TO REGULATION (EU) 2017/745 ON THE CLASS I MEDICAL DEVICES SUBJECT TO RECLASSIFICATION

The date of the definitive application of the Medical Device Regulation (MDR) 2017/745 is close at hand and starting from…

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