New AESGP–IQVIA study highlights the value of self‑care medical devices in Europe

Brussels, 18 May 2026 – Self‑care medical devices play an essential role in supporting the health and well‑being of millions of people across Europe, enabling them to prevent and manage everyday health needs independently and safely. A new report published by the Association of the European Self‑Care Industry (AESGP), based on an extensive market analysis conducted by IQVIA Consumer Health, highlights the value of self‑care medical devices in Europe and the market dynamics shaping their future.

Self‑care medical devices are often taken for granted but are deeply embedded in daily routines across all life stages. We use them for respiratory comfort during cold periods, to keep eye function and everyday oral care; they are essential for skin and wound care and for keeping digestion running smoothly; they play an important part in intimate health and reproductive care to the benefit of overall public health targets.

Self-administered and used without a prescription, self-care medical devices empower individuals to take a more active role in their own health, support prevention, and help relieve unnecessary pressure on healthcare systems.

A significant market but with differences across Member States

According to the IQVIA analysis, Europe’s self‑care overall market reached €250 billion in 2025.

Within this landscape, self‑care medical devices represent a substantial share, contributing with €20.7 billion and accounting for around one‑third of total packs of self-care products.

The study also highlights important differences across Europe. Medical devices’ presence varies significantly, reflecting differences in access, market structures, and consumer habits. This fragmentation between countries can influence product availability and familiarity for people, while adding complexity for companies.

The Medical Devices Regulation (MDR) proposal finally addresses chronic challenges

The self‑care medical devices sector remains dynamic and innovative, reflecting the industry’s ability to respond to evolving everyday health needs and support prevention and self‑management across Europe.

At the same time, the study highlights persistent challenges linked to the implementation of the MDR. Complex procedures with unpredictable costs, lengthy conformity assessments, and inconsistent regulatory interpretations across Member States (in qualification and classification of medical devices) continue to impair manufacturers’ ability to maintain broad product portfolios and bring new solutions to the market, with a particularly strong impact on small and medium‑sized enterprises (SMEs).

AESGP therefore welcomes the European Commission’s recent proposal to modernise, simplify, and overcome shortcomings of EU Medical Devices rules, seeing it as an important opportunity to address long‑standing implementation challenges.

AESGP believes there is room to improve the MDR proposal and calls for supportive and proportionate policies

Self‑care medical devices are a strategic asset for Europe’s health systems, public health objectives, and competitiveness.

Building on its recent Position Paper, AESGP calls on EU institutions to pursue targeted simplification measures and proportionate improvements that:

• strengthen legal certainty and predictability for manufacturers and authorities,
• reduce unnecessary administrative burden, particularly for low-risk products, and
• support innovation, market access, and availability for people across Europe, without compromising user and patient safety.

Oliver Hartmann, Regulatory and Legal Affairs Director of AESGP: “Self‑care medical devices empower people to manage everyday health needs and contribute to more resilient healthcare systems. Policymakers have a key role to play in ensuring that regulation is in place to support innovation, increase availability and improve access for people across Europe.” 

AESGP looks forward to continued constructive engagement with EU institutions as discussions progress on the Commission’s proposal.

Documents

• The Value of Self-Care Medical Devices in Europe, AESGP, 2026
• Self-Care Medical Devices Market Insights – Europe, IQVIA Consumer Health, 2025