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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MARKET ACCESS – AIFA GUIDELINE FOR THE DEVELOPMENT OF PHARMACOECONOMIC ANALYSIS AND MODELLING IN SUPPORT OF THE P&R DOSSIER

The Italian HTA Agency (AIFA) has published the first guideline in order to harmonize the structure and the requirements for…

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MARKET ACCESS – UPDATED CRITERIA FOR THE INCREASE OF PRICES OF MEDICINAL PRODUCTS REIMBURSED BY THE ITALIAN NHS

An update for the increase of prices of medicinal products reimbursed by the Italian NHS has recently been provided by…

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REGULATORY AFFAIRS – COVID-19: EMA INITIATIVES

Due to the current COVID-19 pandemic, EMA has taken lots of initiatives (EMA/213341/2020) to accelerate the development support and evaluation…

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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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