Interdisciplinary Aortic Dissection Symposium – September 6, 2024
Friday September 6th in London, an important symposium specifically focused on the clinical discussion of aortic dissection took place: Interdisciplinary Aortic Dissection Symposium. A large concentration of professionals specialized in the field debated the diagnosis, treatment, and clinical outcomes related to this pathology. The discussion highlighted that there is still no consensus on the indication […]
The International Trade Administration Country Commercial Guide
Italy is moving towards value-based health care. New products that provide better health outcomes in cost-effective ways will be the preferred. The public healthcare system (which makes up 75% of the Italian market) is likely to develop value-based and quality-based pricing models, thereby requesting data and analytics from suppliers for cost-effectiveness assessments. Very innovative products […]
The EU4Health – 2023 work program
On 24th November, The European Commission published the Program for the Union’s action in the field of health (‘EU4Health Programme’) for the period 2021-2027, effectively repealing Regulation (EU) No 282/2014 (OJ L 107, 26.3.2021, p. 1). The priorities and actions, including the allocation of resources, for the implementation in 2023 include an overall budget of […]
The National Recovery and Resilience Plan (NRRP) is an occasion to finance innovation and research
The medical devices industry in Italy is rapidly expanding, and according to data provided by Confindustria Italy, the industry is worth over 16 billion Euros. This outlook is sure to grow as the National Recovery and Resilience Plan (NRRP) will include investments in technologies deemed to “lead to real growth in the National Health System, […]
Eudamed (European Database on Medical Devices) Updated Time line
The European Commission shared a time line for the planning of the outstanding phased releases of the long awaited medical device database in June 2022. Originally scheduled to go live in May 2020, the database aims to register every medical device authorized, to be used across the 27-member European Union. The new time line suggests […]
European regulations for medical devices
New European regulations for all medical devices came into force on 26th May 2021. These regulations require compliance with safety and performance requirements, obliging the manufacturing companies to carry out clinical investigations of available data, and where not sufficient, prepare for further investigations.
Update of Italian Medical Device Spending 2020
The Italian economy in 2021 had a sustained rebound that allowed it to quickly return to the GDP levels of 2019. Thanks to the new data provided by the Ministry of Economy and Finance for 2020, we know that spending on medical devices, excluding large equipment, for the year 2020 amounted to €6,954.3 million (+ […]
The importance of data collection
The Italian lawyer Silvia Stefanelli, an expert in health law, with particular expertise in the field of medical devices and data protection (among others), suggests that following the GDPR that came into force in 2018, the European Legislative framework has a renewed focus on the safety of devices before, requiring the demonstration of clinical benefits […]
Medical devices: imports from Asia increase by 30%
The medical device market “Made in Italy” contracted by 13% in 2021, for a total value of €6 billion. The benefit has been seen in the imports market, exceeded €8.5 billion.
