LEGISLATIVE DECREE 3 SEPTEMBER 2020, N. 116
The Italian authority has recently issued the LEGISLATIVE DECREE 3 September 2020, n. 116 Implementation of directive (EU) 2018/851 amending…
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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – ROUTE TO EUDAMED: THE NEW ACTOR REGISTRATION MODULE ACTIVE SOON
EUDAMED is the IT system developed by the European Commission to implement Regulation (EU) 2017/745 on medical devices and Regulation…
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REGULATORY AFFAIRS – NEW PLATFORM FOR SCIENTIFIC ADVICE
Starting from October 19th, 2020, developers of human medicines should use the European Medicines Agency (EMA)’s IRIS Regulatory & Scientific…
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MARKET ACCESS – NEW DRAFT GUIDELINES ON PRICING AND REIMBURSEMENT DOSSIERS OF MEDICINAL PRODUCTS
Following the publication of the new Decree relevant to the negotiation of Price and Reimbursement of medicinal products (Decree 2nd…
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MARKET ACCESS – NEW ITALIAN DECREE ON THE PROCEDURES FOR PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS PUBLISHED IN THE ITALIAN OFFICIAL JOURNAL
After almost a year of waiting, the new Decree from the Italian Ministry of Health and the Ministry of Economy…
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MEDICAL DEVICES – TECHNICAL FILE ACCORDING TO MDR REQUIREMENTS – THE IMPORTANCE OF GAP ANALYSES WITH “OLD” DIRECTIVE TECHNICAL FILE
Although the European Commission postponed the entry into force of the Medical Device Regulation until May 2021, this is not…
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MEDICAL DEVICES – SAFETY REPORTING FOR MD CLINICAL INVESTIGATION UNDER MDR
The MDCG has recently issued a new guideline to outline the clinical investigation reporting procedure. According to the guideline the…
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MEDICAL DEVICE – ITALIAN DEROGATION PROCEDURE FOR COMMERCIALIZATION OF NON-CE MARKED DEVICES
The Italian Ministry of Health (MoH) has issued an explanatory note reporting how to place medical devices not compliant with…
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MARKET ACCESS – SIHTA POSITION PAPER
The Italian HTA Society (SIHTA) has recently published a Position Paper which aims at indicating a possible evolution of the…
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QUALITY ASSURANCE – QUALITY SYSTEM & REMOTE AUDITS DURING COVID-19 EMERGENCY
On 11th March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. Covid-19 Emergency has put a…
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