MDR Implementation Challenges could impact 40% of consumer healthcare market

IQVIA publishes study on dynamics of self-care medical devices in Europe

Brussels, 21 February 2024 New paper published by IQVIA Consumer Health, with the collaboration of AESGP, reveals a clearer picture of the self-care medical devices market in Europe. The study looks at the market size, key categories, and dominant product areas across 19 European countries, while also addressing the opportunities and challenges that this innovative and growing sector presents.

Traditionally, the European consumer health market narrative has been influenced by non-prescription medicines. However, the role of self-care medical devices in the market must not be neglected given their therapeutic importance and the fact they can offer a unique self-care choice to people.

Self-care medical devices are wide in variety and involve products commonly used for the treatment of common ailments such as cold, skin irritation, abdominal pain, as well as for contraception or prevention of the transmission of sexually transmitted diseases. They are generally available over the counter without a medical prescription and are self-administered. Specific product examples include plasters, condoms, salt water nasal sprays, lubricating eye drops, dermal creams or gels, etc.

An innovative and growing sector in the European consumer health market

Until now, it has been difficult to get a picture of how big the self-care medical devices market is in Europe, what categories dominate the self-care medical devices landscape and where the challenges and opportunities lie.

IQVIA Consumer Health and AESGP collaborated on a data-analysis project to define, for the first time, the market size and trends for the self-care medical devices market across Europe. Analysing market data between 2019 and 2022, the project revealed that:

  • In 2022, self-care medical devices accounted for 40% of value sales to the wider Consumer Health market, and 43% of new pack launches over the past 2 years to 2022.
  • The European self-care medical devices market can be broken down into three main categories: Patient Care (e.g.: at home coronavirus or glucose measuring tests); Over-the-counter or “OTC” (e.g.: throat lozenges; eye drops); and Personal Care (e.g.: denture products; intimate hygiene).
  • The Patient Care is the dominant category, accounting for 70% of the self-care medical device sales across Europe. Over the past 2 years to 2022, this category contributed to 86% of new launches across the self-care medical devices market in Europe.
  • Accounting for 27% of medical devices sales, the OTC Medical Devices category is the second largest share in medical devices values led by eye care and CCR products (cough, cold and respiratory). This category accounted for 13% share of total new packs launched.
  • The Personal Care category accounts for just 3% of value sales in 2022. The category is seemingly stagnating in terms of innovation, contributing just 1% of new product launches in the past 2 years to 2022.


Implementation of the MDR: between challenges and opportunities

Currently, the European self-care medical devices market environment faces many challenges posed by the roll-out of the Medical Devices Regulation (MDR). Challenges encountered in the certification process have led to a situation where transitioning to the MDR has been limited. In categories such as Patient Care, where sales make up 70% of the market value, MDR implementation issues can pose a real risk of bottlenecks, shortages or unavailability of certain medical devices for people needing them.

Self-care medical devices are an established and vital part of the European Consumer Health market. While ensuring a high level of safety and health protection, it is essential to sustain the volume and growth potential of those products under the MDR by creating the same favorable market conditions, notably in terms of efficiency, transparency, predictability and innovation.

Addressing these challenges properly will create the adequate regulatory conditions for the self-care medical devices market, ensuring swift market access for new products and reinforcing its the crucial role in supporting the health and well-being of consumers across Europe.


Read the full analysis

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