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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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…

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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….

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CLINICAL TRIALS – INCREASE IN ITALY: AIFA REPORT FOR 2018

The Italian Medicines Agency (AIFA) has published the 18th National Report on Clinical Trials of Medicines in Italy, containing data…

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MARKET ACCESS – THE ACKNOWLEDGMENT OF THE INNOVATIVE STATUS FOR MEDICINAL PRODUCTS IN ITALY

The algorithm used by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) to assess the innovation of medicinal products…

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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – TRANSITIONAL PROVISION CONCERNING VALIDITY OF CERTIFICATES ISSUED IN ACCORDANCE TO DIRECTIVE 93/42/EEC

26 May 2020, the date of entry into force of Regulation (EU) 2017/475 on Medical Devices (the MDR), it is…

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