Medical devices – European Commission, medical law.#Medical #law

Posted On Jul 3 2018 by

Medical devices

The role of medical devices is essential to the healthcare of EU citizens. The diversity and innovativeness of this sector contributes significantly to enhancing the safety, quality and efficacy of healthcare in the EU.

Covering a wide range of products, from simple bandages or sticking plasters to the most sophisticated X-ray equipment, the medical devices sector plays a crucial role in the diagnosis, prevention, monitoring and treatment of diseases. It also helps improve the quality of life of those with disabilities.

The importance of the medical devices sector

The medical devices sector helps save lives by providing innovative health care solutions regarding diagnosis, prevention, monitoring, treatment and alleviation of disease. The sector has become increasingly important for the healthcare of EU citizens and an influencer of expenditure.

  • The medical devices industry is a major employer in Europe, employing 575,000 people in the EU.
  • Total sales amount to EUR 100 billion.
  • The sector represents some 25,000 companies, of which 95% are Small and Medium-sized Enterprises (SMEs).

Challenges faced by the sector

The medical devices sector faces many challenges at national, European and international level, which may have an impact on their innovation capacity and overall competitiveness:

  • Public Health Systems
    • In particular, emerging needs such as developing a shared understanding of healthcare goals, overcoming health inequalities, an ageing society and exploiting the potential of e-health technologies.
  • Finding the balance between patient’s needs and financial sustainability
    • Ensuring that the sector can enhance better access for patients to devices whilst simultaneously ensuring that pricing and reimbursement policies are effective;
  • Competitiveness and innovation
    • Challenges related to R D, emerging technologies and the green economy, as well as issues related to the EU’s trade and regulatory cooperation globally. SMEs in particular face challenges in this regard.

What the Commission is doing

Enhancing competitiveness is one of the key objectives of the European Commission. As a result, the Commission regularly liaises with industry associations to explore ways of helping enterprises and maintain growth.

In order to help the sector to overcome both public health and industrial challenges, an ‘Exploratory process on the future of the medical devices sector’ was implemented in 2009.

  • Final Report (2010) (71 kB)
  • Background to the process (234 kB)
  • A number of publications are also available to help inform and support the industry as regards improving competitiveness.

Last Updated on: July 3rd, 2018 at 5:34 pm, by

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