The Italian and European medical device sector is grown steadily in the last decade, thanks to the ever-present demand for innovative appliances, which leads to greater investment in research and development and the design of cutting-edge medical technologies.
The production sector of medical devices in Italy
The medical device sector in Italy generates a market that is estimated to be around 16,5 billions of euros between exports and the internal market, according to the most recent elaboration of the Confindustria Medical Devices Study Center. The national production sector is fed with companies – I'm 4.546 – offering jobs a 112.534 employees. The actors of this industrial sector - although very heterogeneous - consist of majority in small and medium-sized enterprises, often highly specialized, which coexist with relatively few companies and large groups. The entrepreneurial fabric, indeed, sees a net prevalence of SMEs – about the 94% of the total - with respect to macro-companies. Numerically, as well as national, I'm 2.523 companies that produce medical devices.
The medical device manufacturing sector is an extremely differentiated universe in terms of production: I'm 1315 companies that deal with biomedical, 602 those operating in the biomedical instrumental sector e 510 are interested in substance-based devices. It's’ Interestingly, companies that are engaged in producing electronic devices are growing sharply compared to last year: 360 are those relating to electro-medical (+ 42 compared to the previous year) and 237 those relating to the field "Home & Digital Care", increase by 50 reality compared to 2020. A focal role is played by start-ups and innovative SMEs active in the sector, that I am 298 in total. These companies are characterized by a strong innovative profile, extremely skilled employment and huge investments in Research and Development.
The European framework and import / export
The European medical technology market is grown on average of 2% per year in the last 10 years and was valued at approx 140 billions of euros in 2020. The largest medical device markets in Europe are Germany, France, Italy and Spain. The same group of countries are the first 5 IVD markets in Europe.
Based on manufacturers' prices, it is estimated that the European market of medical devices represents about 27% of the world market, positioning itself as the second most important market after that of the United States (41%).
On the subject 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 assess compliance of new products. As it is known, the CE marking of medical devices it is an absolutely mandatory procedure for all products governed by the Community Regulations defined as "medical devices and in vitro medical devices". Core responsibility of the manufacturer – but also of the importer and distributor - with the declaration of conformity for medical devices we declare that the products in question comply with the health and safety 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, consulting and business support company. Together with Tsemplifico, which makes the drafting of technical files in the medical field one of its strengths, Sicom carries on all the technical tests necessary for placing medical products on the market, thus offering an even more complete and profiled service.
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