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Council discusses safety of medical devices

Meeting on 19 and 20 June in Luxembourg, the Employment, Social Policy, Health and Consumer Affairs Council looked at ways of improving the safety of medical and in vitro devices in the EU.

Medical devices

Ministers discussed ongoing work on changes to the draft legislative package on medical devices and in vitro diagnostic medical devices.

The proposed law seeks to modernise the current rules to make sure that the devices are safe and can be traded across the EU. It aims to step up scrutiny of products before they enter the market and tighten surveillance after they become available. The draft legislation covers a broad range of products: from plasters and pregnancy tests to state-of-the-art pacemakers, X-ray machines and in vitro diagnostic products.

Ministers exchanged views on 3 issues:

  • the designation and monitoring by EU countries of the so-called "notified bodies" in charge of certifying certain medical and in vitro devices before they enter the market
  • the participation of businesses in the surveillance of the safety of devices placed on the market
  • the responsibilities of the medical devices coordination group

Following the discussion, the Council asked its preparatory bodies to continue work in order to establish a Council position on the package.

Medical and in vitro devices in the EU

There are over 500 000 medical and in vitro devices on the market.

The sector employs over 500 000 people in about 25 000 companies, most of which are micro, small and medium entreprises.

They generate nearly EUR 100 bilion in annual sales in the European market and invest heavily in research and development. About 6-8% of medical devices annual sales and 10% of in vitro devices annual sales is re-invested in research every year.       

Economic crisis and healthcare

Ministers have also adopted conclusions on economic crisis and healthcare. They suggest ways to make the sector more resilient to future shocks. These include:

  • greater integration of primary and hospital care 
  • better use of information and communications technologies 
  • development of e-health services.

Council conclusions on the economic crisis and healthcare

Nutrition and physical activity

The Council has also endorsed conclusions on nutrition and physical activity. Given that up to 7% of EU health budgets are spent each year on disease linked to obesity, ministers proposed measures to encourage the promotion of physical activity and a healthy diet.

Council conclusions on nutrition and physical activity

Other main items on the agenda

Women on company boards

The Council took note of a presidency's progress report on a draft directive improving the gender balance among non-executive board members. The proposal aims to increase the share of women to 40% of non-executive posts in publicly listed companies by 2020.

To achieve this binding objective, it foresees no mandatory female quotas but introduces fairer selection mechanisms instead.

Ministers supported the principle of improving the gender balance on company boards, yet they differed on the best ways to achieve it. While some were in favour of national measures and non-binding EU rules, others supported EU-wide legislation.

The Council will continue further work before a compromise can be reached.

Women on corporate boards in the EU

Large companies in the EU are disproportionately led by men. Women account for an average of 17.8% of top-level board members in the biggest publicly listed companies in EU countries. Just 4.8% of the chairpersons of these companies and only 2.8% of CEOs are women.

The Council has also adopted conclusions on women's economic independence from the perspective of part-time work and self-employment. The document calls on EU countries and the Commission to promote the participation of women in the labour market and support work-life balance for men and women.

Council conclusions on "Women and the economy: Economic independence from the perspective of part-time work and self-employment" 

European Semester 2014

Ministers held a policy debate on employment and social policy measures to be included in country-specific recommendations.  

These recommendations offer tailored advice on action that each EU country should pursue in a number of policy areas, ranging from public finances and pension schemes to innovation challenges and competition. Agreed by various Council configurations and endorsed by EU leaders at the European Council, they are part of the European Semester, a yearly cycle of economic policy coordination among member states.  

During the debate, the Council acknowledged ambitious labour market reforms carried out by EU countries. Ministers pointed to high levels of unemployment, including that of young people and women, growing poverty, sustainability of social protection schemes and pensions as areas where further action was needed.

The result of discussions will feed into the country-specific recommendations due to be endorsed by the European Council at its meeting on 26-27 June.  

The Council has also adopted a report on the implementation of the Youth Guarantee. This policy initiative aims to provide under-25s with a job or training within four months of finishing education or being unemployed.

Report on the implementation of the Youth Guarantee

In a related discussion, ministers exchanged views on the social dimension of the European Union and the European Monetary Union.

Discussions focused on four issues:

  • coordination of economic, social and employment policies
  • coordination of plans for major social policy reforms
  • minimum income schemes in the euro area
  • social protection for long-term care for people in an ageing society

EU platform against undeclared work

The Greek Presidency briefed the Council on the state of play of a draft decision to establish an EU platform against undeclared work. The Platform would bring together the national bodies combating undeclared work to promote joint actions as well as facilitate exchange of best practices and information.


Ministers also heard a Presidency presentation on a draft law improving the efficiency of EURES, or the European Employment Services Network. The proposed legislation seeks to boost cross-border labour mobility by improving access to job opportunities throughout the EU.

Video highlights

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