MEDICAL DEVICES – HOW TO SET UP CLINICAL EVALUATION IN COMPLIANCE WITH THE REGULATION (EU) 2017/745 FOR MEDICAL DEVICES ALREADY MARKETED UNDER DIRECTIVES 93/42/EEC OR 90/385/EEC

To confirm the compliance with the General Safety and Performance Requirements (GSPR) of the MDR, a clinical evaluation shall be…

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MEDICAL DEVICE – REGULATORY REQUIREMENTS FOR VENTILATORS AND RELATED ACCESSORIES IN PILLS

Considering the COVID-19 pandemic there is a huge and increasing need of ventilators to be used in particular with most…

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MEDICAL DEVICES and PERSONAL PROTECTIVE EQUIPMENT – NON-COMPLIANT CE CERTIFICATES AND HOW TO RECOGNISE THEM

In order to be placed on the European Market, a medical device (MD) shall comply with one of the relevant…

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MEDICAL DEVICES – PROTECTIVE MASKS: REGULATORY REQUIREMENTS IN PILLS

Considering the COVID-19 pandemic there is a huge and increasing need of protective devices, protective masks in particular. Protective masks…

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REGULATORY AFFAIRS – EXPECTATIONS DURING COVID-19: RENEWALS AND “SUNSET CLAUSE”

The Q&A developed by European Commission, EMA and the European medicines regulatory network provides guidance to companies on adaptations to…

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REGULATORY AFFAIRS – FLEXIBILITY FOR COVID-19 TREATMENTS

A Q&A document has been made available by the European Commission to provide guidance to MAHs, including clarifications regarding the…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – PUBLICATION OF THE MDR APPLICATION POSTPONEMENT

Due to the COVID-19 emergency, the European Commission proposed to postpone by one year the date of application of the…

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PHARMACOVIGILANCE – ADVERSE REACTIONS REPORTING DURING THE COVID-19 PANDEMIC

During the current pandemic, the reporting of adverse events related to the widespread use of medicinal products (including off-label use)…

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REGULATORY AFFAIRS – COVID-19 RESTRICTIONS: WHAT TO KNOW ABOUT GMP/GDP ISSUES

Covid-19 pandemic has led to different restrictions that may also have an impact on some on-site Good Manufacturing Practices (GMP)…

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CLINICAL TRIALS – SIMPLIFIED PROCEDURES FOR CT AND OBSERVATIONAL STUDIES FOR COVID-19 TREATMENT

Following the Legislative Decree n.18 of 17/03/2020, AIFA has published a Circular indicating the simplified procedures for the data acquisition…

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