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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MEDICAL DEVICES – EUROPEAN REGULATION 2017/745 – THE RULE 21: HOW THE CLASSIFICATION OF DEVICES COMPOSED OF SUBSTANCES IS GOING TO CHANGE
One of the main changes that will most affect the Medical Device regulatory field is included in Annex VIII of…
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REGULATORY AFFAIRS – NITROSAMINES: WHICH STEPS SHOULD BE TAKEN?
In June 2018, N-nitrosodimethylamine (NDMA) and similar compounds known as nitrosamines, classified as probable human carcinogen based on animal studies,…
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MEDICAL DEVICES– THE IMPLANT CARD FOR PATIENT WITH AN IMPLANTED DEVICE
Regulation EU 2017/745 introduced a new requirement for the manufacturer of implantable medical device. The manufacturers of implantable devices must…
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MEDICAL DEVICES – REQUIREMENTS REGARDING THE INFORMATION SUPPLIED WITH THE DEVICE
Starting with the entry into force of the new European Regulation 2017/745 on May 2020, the information on medical devices…
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MARKET ACCESS – NEW ITALIAN DECREE ON THE PROCEDURES FOR PRICING AND REIMBURSEMENT OF MEDICINAL PRODUCTS
On 1st August 2019, the text of a new Decree from the Italian Ministry of Health and the Ministry of…
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