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1 Market overview

1.1 Definition and scope of study

A medical device is defined in Regulation 2017/745/EU as "an instrument, apparatus, equipment or software intended by its manufacturer to be used for the diagnosis, prevention, control, treatment of disease, injury or other purposes".

The market can be broken down into numerous segments or compartments, in terms of destination of the equipment or type. Below is a distinction by category of medical device:

  • Medical devices for individual use (e.g. hospital equipment, anesthesia or respiratory equipment)
  • Equipment (e.g. dental equipment);
  • In vitro diagnostic medical devices (e.g. pregnancy tests, glucometers);
  • E-Health (monitoring of physiological parameters at home in real time).

The medical device market is strongly influenced by European and Italian regulations which, in the future, could contribute to a slowdown in growth due to the high costs to comply with imposed regulations in the sector. Nevertheless, the Italian market is growing, driven by an impressive domestic production, represented by 2100 firms in 2019, destined to satisfy both national and international demand – with circa 44.7% of the Italian market exported. The ageing population and the increase in life expectancy continue to have a strong influence on the growing market. The latter presents a highly concentrated geographical image both in terms of the number of companies – with 1/3 of companies aggregated in solely 1 region - and their turnover; but this does not discourage the birth of highly innovative startups all over the territory.

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the medical equipment market | Italy

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