Ireland EU Presidency, to influence Medical Device Regulations

On January 1st 2013, Ireland took over the presidency of the Council of the European Union under the presidency trio of 2013-2014 (Ireland, Lithuania & Greece). Ireland presidency will be between, January 1st 2013 till June 30th 2013. This will be the 7th time Ireland holds this office and it coincides with the 40th anniversary of Ireland joining the European Union (1973).

The Presidency of the Council of the European Union rotates between the member states of the EU every 6 months, called Presidency Trio. This position is not held by one person, but by a national government.

The aim of the Presidency of the Council of the European Union is to:

  • Settle agendas and programs (e.g. “priorities”);
  • Chair meetings of the Council and act as an honest-broker at the Council meetings as well as with other EU

Institutions;

The previous Presidency Trio was Poland, Denmark and Cyprus. Cyprus handed over the EU presidency to Ireland as it held the EU presidency from July 1st 2012 till December 31st 2012. Cyprus underlined the importance of a new medical device legislation by introducing the new proposals for medical device regulation, during its presidency.

On January 9th 2013, the program of the Irish Presidency was officially published on the Irish presidency website (eu2013.ie). Ireland emphasized the prioritization of the progression of proposal 2012.541 (on In-Vitro Diagnostics to repeal the IVDD 98/79/EC) and proposal 2012.542 on Medical Devices (to repeal the MDD 93/42/EEC & the AIMDD 90/385/EEC) as part of its health policy for EU citizens within its presidency program.

The new proposals for medical device regulations will present new and in some cases more stringent set of requirements on health care professionals, including Notified bodies, Authorized Representatives and medical device manufacturers wishing to introduce CE Marked medical devices onto the EU Market.

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in Industry News Active Implantable Medical Devices, Industry News In-Vitro Diagnosis, Industry News Medical Devices, News