In recent years, Europe’s natural-substance medical device sector has grown significantly, especially in self-care for chronic and functional conditions. The Medical Device Regulation (EU) 2017/745 (“MDR”) has supported this growth by enforcing strict standards for efficacy, safety, quality, and post-market surveillance.
However, it has also introduced excessive regulatory and procedural burdens, which have limited innovation within the sector. To address these challenges, the European Commission has published a new legislative proposal, maintaining the same high standards for product evaluation while simplifying the regulatory framework and fostering innovation.
The recently published proposal appears to achieve many of the objectives underpinning the revision. During the legislative process, however, it will be essential to ensure that sector governance based on the so-called “New Approach” is preserved. This approach assigns the definition of essential requirements to EU legislation and entrusts notified bodies with product assessment and certification, avoiding centralized procedures that could undermine competitiveness and innovation.
EU legislators, through the MDR, have recognized the therapeutic value of the non-pharmacological action of complex natural substances, fostering innovation, clinical research, and access to safe, effective natural products. Aboca is an example of a company that is investing significantly in this sector.
The key challenge is to advance a people-centered vision of health that balances innovation, safety, and sustainability
Founded in Tuscany in 1978, Aboca is now one of the leading European players in the field of natural health. The company develops medical devices and food supplements based on complex natural substances, supported by an integrated supply chain ranging from organic agriculture to pharmaceutical production and international distribution.
With over 1,800 employees and a presence in 24 countries, including an office in Brussels, Aboca stands out for its commitment to scientific research, environmental sustainability, and transparency. Since 2015, Aboca has invested in the field of natural medical devices, allocating approximately €8 million annually to research and development.
Aboca applies Systems Biology and Systems Medicine to develop evidence-based products from complex natural substances, according to One Health criteria. The company produces medical devices designed to address mild diseases, chronic conditions and functional disorders that impact respiratory, digestive and metabolic systems.
Since 2015, Aboca has invested in the field of natural medical devices, allocating approximately €8 million annually to research and development
These devices differ from traditional medicines in that they act through a non-pharmacological mechanism: the complexity of their natural matrix enables a multifactorial mode of action rather than targeting specific receptors, supporting the restoration of physiological balance.
Clinical research, safety, and sustainability
Scientific research is central to the development of Aboca’s natural medical devices. Randomized clinical trials, real-world data, and continuous post-market surveillance ensure efficacy and safety. These devices expand the therapeutic options available, addressing unmet medical needs and improving the quality of life of the most vulnerable population groups.
A distinctive feature is environmental sustainability: the biodegradability of natural substances and the absence of artificial additives reduce the environmental impact of therapies, making them consistent with the One Health principle.
Looking to the future
The key challenge is to advance a people-centered vision of health that balances innovation, safety, and sustainability. Through strong science, effective regulation, and continued dialogue among companies, institutions, and researchers, Europe can address unmet health needs and reinforce its global leadership.
Find out about Aboca's work in the field of natural health
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