Employment, Social Policy, Health and Consumer Affairs Council, 01/12/2014, 1 December 2014

Council discusses safety and innovation in medical devices

Meeting in Brussels on 1 December, health ministers discussed draft legislation that seeks to improve the safety of medical and in vitro devices in the EU.

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 enterprises.

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

Medical devices

Ministers discussed progress in talks on 2 draft regulations on medical devices and in vitro diagnostic medical devices, which were tabled by the European Commission.

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

The progress report, which was drafted by the Italian presidency, shows issues where further discussion is needed to hammer out the Council's position. These include:

• a unique device identification system, which would make it easier to recall faulty products and help to fight against counterfeit devices
• so-called 'notified bodies', like a laboratory or national standards authority, that check if devices meet the applicable standards
• the role of the medical device coordination group, which, it is proposed, will involve assessing high-risk devices before they enter the market
• post-market surveillance

Following discussions, the presidency intends to draft a text that can be used by the Latvian presidency, starting in January, to conclude the work on the proposal.

Vaccination

In conclusions on vaccinations as an effective public health tool, the Council asked member states to:

• improve vaccination plans in their countries
• make sure that vaccine evaluations are carried out in a transparent manner
• offer right vaccines to risk groups  

They also called for more research and innovation to develop new vaccines. In the same vein, they invited the European Commission to provide EU funding for that purpose.

Patient safety and innovation

In a set of conclusions on patient safety and innovation for the benefit of patients, ministers asked member states to:

• promote education and training of healthcare staff on patient safety
• develop blame-free reporting by healthcare staff or patients and blame-free handling of errors
• strengthen programmes to prevent infections
• encourage patients and their families to have a say about their treatment     

They have also called for the speeding up of assessment and approval  procedures for new medicines.

Europe 2020 review

Ministers discussed how investments in health care systems can contribute to achieving the goals of the Europe 2020 strategy. Launched in 2010, the strategy set five targets on jobs, poverty reduction, education, innovation, and climate and energy to be reached by 2020. 

A number of ministers suggested that the role of good health of Europeans in achieving the strategy's targets, such as employment or research, should be better reflected. However, ministers have not supported the idea of creating a new specific target related to health.      

Ministers' discussions revolved around a number of issues:

• ways of investing in healthcare systems
• the need for more EU action to tackle differences in the performance of national health systems

The outcome of ministers' discussions will feed into a report that the Italian presidency will present to EU leaders meeting at the summit in December. The report will give the European Commission guidance on improving the strategy's implementation.  

The Commission launched a public consultation on the review of the strategy in May and is expected to make specific proposals in early 2015.