The Italian and European medical device sector is grew steadily in the last decade, thanks to the ever-present demand for innovative devices, which leads to greater investments in research and development and the design of cutting-edge medical technologies.
The medical device production sector in Italy
The medical device sector in Italy generates a market estimated at around 16.5 billion euros between exports and the domestic market, according to the most recent elaboration of the Confindustria Medical Devices Study Center. The national production sector is full of companies - there are 4,546 - which offer jobs to 112,534 employees. The players in this industrial sector – although very heterogeneous – consist of majority in small and medium-sized enterprises, often highly specialized, coexisting with relatively few companies and large groups. The entrepreneurial fabric, in fact, sees a clear prevalence of SMEs – about the 94% of the total – compared to macro-companies. At a numerical and national level, there are 2,523 companies that produce medical devices.
The medical device production sector is an extremely differentiated universe at a production level: there are 1315 companies that deal with biomedical, 602 those that operate in the instrumental biomedical sector and 510 are interested in substance-based devices. It is interesting to note that the companies that deal with producing electronic devices are growing sharply compared to last year: 360 are those relating to electromedical equipment (+42 compared to the previous year) and 237 those relating to the "home & digital care”, increased by 50 entities compared to 2020. The focal role is that played by innovative start-ups and SMEs active in the sector, which are 298 in total. These companies are characterized by a strong innovative profile, extremely qualified employment and huge investments in Research and Development.
The European framework and import/export
The European medical technology market is grown on average by 2% per year over the last 10 years and was valued at approx 140 billion euros in 2020. The largest medical device markets in Europe are Germany, France, Italy and Spain. The same group of countries makes up the top 5 IVD markets in Europe.
Based on manufacturer prices, it is estimated that the European market of medical devices represents approximately 27% of the world market, positioning itself as the second important market after the United States (41%).
In terms of import/export, considering only the European level, Italy ranks 15th for export in the sector. Exports are worth 5.7 billion euros (with a growth of 7.9% compared to the previous year), while imports are worth 8.1 billion euros (with an increase of 5.5% compared to 2020).
Compliance of medical devices
Given the great expansion of the production sector, the changes to community regulations on medical devices and the ever-increasing demand for new devices, there is an increase in the need to evaluate the conformity of new products. As is known, the CE marking of medical devices it is an absolutely mandatory procedure for all products governed by Community Regulations defined as "medical devices and in vitro medical devices". Key responsibility of the manufacturer - but also of the importer and distributor - with the declaration of conformity of medical devices we declare that the products in question comply with the safety and health requirements established by the regulations.
To respond to the growth of the sector and offer an integrated service to companies that produce medical devices, Sicom Testing has entered into an agreement with Tsemplifico, a consultancy and business support company. Together with Tsemplifico, which makes the drafting of technical files in the medical field one of its strong points, Sicom carries out all the technical tests necessary for placing medical products on the market, therefore offering an even more complete and profiled service.
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