The presidency of the Council of the European Union changes hands every 6 months among the member countries. Since the beginning of last January, and until the end of June 2016, it is the turn of the Netherlands, and all indications are that it will be in charge of publishing the final text of the new Medical Devices Regulation. Although there has been no official announcement, the Netherlands' predecessor was Luxembourg, and after its presidency, Slovakia and Malta will follow. Therefore, all the betting pools suggest that it will be during the Dutch presidency.
Calendar of EU presidencies
Netherlands: January-June 2016
Slovakia: July-December 2016
Malta: January-June 2017
United Kingdom: July-December 2017
Estonia: January-June 2018
Bulgaria: July-December 2018
Austria: January-June 2019
Romania: July-December 2019
Finland: January-June 2020
Until now, Medical Devices in Europe have been regulated by European Commission Directives, and these are incorporated into the legislation of the member country through a transposition, which, in the case of Spain, turns them into a Royal Decree. At present, the regulations on Medical Devices are governed by Directive 90/385/EEC -which in Spain was implemented through Royal Decree 1616/2009-, Directive 93/42/EEC -in our country Royal Decree 1591/2009 was created- and, finally, in the case of medical devices for “in vitro” diagnosis, Directive 98/79/EC - Royal Decree 1662/2000, and some minor updates.
However, during this presidency, the new Medical Devices Regulation -a legal figure above the Directives- is expected to be published, and it will have direct application for the whole EU, that is to say, it will be translated in the member countries, but it will not be translated or undergo modifications. At GTF M. Camps we hope that this document, drafts of which were already appearing last year among professionals in the sector, will certainly be published during the Dutch presidency.