login
login
Image header Agence Europe
Europe Daily Bulletin No. 11628
Contents Publication in full By article 28 / 29
NEWS BRIEFS / Health

Political agreement at EU Council on medical devices

20/9/2016 (Agence Europe) The permanent adoption of new rules governing the marketing and follow-up of medical devices is getting closer. The Council of the European Union endorsed the political agreement on Tuesday 20 September prior to the two draft regulations (medical devices and in vitro medical devices). Lawyer-linguist experts now have to re-read the text so that the Council can adopt its position in the first reading and the European Parliament can endorse it in an early second reading so that the new rules can be adopted. These rules strengthen the monitoring of products deemed dangerous and provide more power to the notified bodies (the third-party public bodies or private companies appointed by the member states, which authorise the marketing of devices containing the "EC" label) (see EUROPE 11559). The aim is to avoid any further health scandals, such as that of the adulterated breast implants in 2010 or of the metal hip replacements in 2012. (SPj)

Contents

INSTITUTIONAL
EXTERNAL ACTION
ECONOMY - FINANCE - BUSINESS
COURT OF JUSTICE OF THE EU
SECTORAL POLICIES
SOCIAL AFFAIRS - EMPLOYMENT
NEWS BRIEFS