Brussels, 17/06/2015 (Agence Europe) - On Friday 19 June, medical devices and in vitro medical devices (in addition to miscellaneous points) will be the only subjects on the ministerial agenda for the “Employment, Social Policy, Health and Consumers” Council session.
The Council will be chaired by the Latvian Minister for Health, Guntis Belevics, and is expected to reach a political agreement on the two drafts in the regulation. The dossier has been debated for the past two and a half years. The European Parliament has already adopted its position in a first reading a year ago (see EUROPE 11054) and is beginning to get impatient about starting the trialogue negotiations.
During the most recent formal Council 1 December 2014, the Italian Presidency was unable to conclude the dossier, because there were still too many questions pending, mainly of a technical nature. The following questions are involved: aesthetic devices, the withdrawal of single use devices, the single identification system for medical devices, notified bodies, clinical trials, the tasks of the medical devices coordination group that it is proposing to set up, the role of expert committees and reference laboratories, the control mechanism for certain high risk devices and monitoring following the marketing of products.
The revision of the legislative provisions on medical products seeks to enhance the traceability of equipment and ensure the highest possible level of patient protection and health professionalism in Europe, whilst avoiding any restrictions on innovation in the sector and the availability of devices to patients. The breast implant scandal (PIB) at the end of 2011 highlighted the shortcomings in current legislation in this connection. (Isabelle Lamberty)