The first item concerns COM (2012) 541, a proposal for a regulation of the European Parliament and the Council on in vitro diagnostic medical devices, and COM (2012) 542, a regulation of the European Parliament and the Council on medical devices, amending Directive 2001/83/EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009.
The proposed regulations will replace the existing suite of directives currently in place for medical devices. The Commission proposes important changes on various aspects relevant to the life-cycle of medical devices such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities.
The aim of the two proposed regulations is to provide a legislative framework for the manufacture and placing on the market of both medical devices and in vitro diagnostic medical devices which ensures a high level of protection for patients and health care professionals and which is fit for purpose, more transparent and better adapted to scientific and technological advances. The proposed regulations are expected to be adopted in 2014 and will gradually come into force from 2015 to 2019. Having reviewed the proposed regulations, it is proposed that the committee write to those involved in the industry in Ireland to seek opinions on them. Is that agreed? Agreed.