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…

READ

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…

READ

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…

READ

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…

READ

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…

READ

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…

READ

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…

READ

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…

READ

MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – GENERAL OBLIGATIONS FOR IMPORTERS

The EUROPEAN REGULATION 2017/745 (MDR) will formally introduce the role of the “importer” defined as any natural or legal person…

READ

MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 –FOCUS ON THE MAIN ASPECTS OF THE ARTICLE 15 AND THE PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE

26 May 2020 is the date of the definitive application of the European Regulation 2017/745 (MDR 2017/745) on Medical Devices….

READ