Brussels, 01/12/2014 (Agence Europe) - On Monday 1 December, the Health Council took note of the Italian Presidency's report on the state of progress in work on the two draft regulations, one on medical devices and the other on in vitro diagnostic medical devices. A dossier which has been on the table for the last two and a half years.
Despite its determination to reach a general orientation under its Presidency and the ten technical meetings it has held to this end, Italy has resolved to hand the dossier over to the Latvian Presidency for it to continue the work. There are still too many questions outstanding and Italy “does not want to force the delegations' hands”, with no compromise having emerged in the course of the preparatory work, the Italian Health Minister, Beatrice Lorenzin, announced with regret. She is, however pleased to have been able to hand over to Latvia a full clarification text on both proposed regulations.
The European Commissioner for Health, Vytenis Andriukaitis, lamented the absence of consensus and called on the member states to abandon technical discussions to take a political initiative. “In order to reach an agreement, I insist that the states must move away from their own positions and move closer to those of the others, that is going to be vital”, the Commissioner stressed. Once the Council has adopted its position, it will be able to start trialogue talks with the European Parliament.
There are still many questions under discussion. Amongst other things, these relate to aesthetic devices, the withdrawal of single-use devices, the single identification system for medical devices, the notifying bodies, clinical investigation, the responsibilities of the proposed medical devices coordination group, the role of the expert panels and reference laboratories, the control mechanism for certain high-risk devices and post-sales monitoring.
A few delegations took the floor after Lorenzin, amongst them France, which is in favour of an a priori control mechanism for high-risk medical devices to ensure systematic prior assessment and stressed that this system would not make it take any longer to get the product to market, as this evaluation would be carried out alongside the CE labelling work carried out by the notifying body. Germany expressed its willingness to move forward by adopting a rigourous framework and starting the trialogue sessions with the European Parliament as quickly as possible (the United Kingdom made the same comment). The Netherlands expressed concern at the fact that the financial impact of the procedures has been neglected as the discussions have moved forward. They are therefore calling for a financial impact assessment. Latvia, which will take the Presidency of the Council over from Italy on 1 January, called in conclusion on the “member states to show openness to compromise and to focus on the main stumbling blocks”. (IL)