Commission position on the European Parliament amendments:
On 26 September 2012, the European Commission adopted a package on innovation in health consisting of:
The Commission proposals are accompanied by an impact assessment on the revision of the regulatory framework for medical devices that consists of:
The proposals have been submitted to the European Parliament and the Council. In order to become binding Union law, Parliament and Council need to adopt the texts by ordinary legislative procedure. You find an overview of this procedure on the website of the European Parliament. You can follow the development of the legislative decision-making process on Pre-Lex or on the “Legislative Observatory” of the European Parliament.
After the last amendment of Council Directives 90/385/EEC and 93/42/EEC by Directive 2007/47/EC (see below), the Commission considered a fundamental revision of the regulatory framework for medical devices necessary in order to ensure a high level of human health and safety, to ensure the smooth functioning of the internal market and to meet the growing expectations of European citizens while preserving its innovation-friendly approach.
On 8 May 2008, the European Commission published a public consultation document to seek the views from stakeholders on the revision of the legal framework for medical devices (“recast”). The 200 responses were summarised in a summary report and the individual responses published on the Commission’s website.
To complement the first consultation, the European Commission launched, on 29 June 2010, a public consultation on technical aspects related to the revision of Directive 98/79/EC on in vitro diagnostic (IVD) medical devices. The public consultation document is available here . The summary report and the 183 responses were published on the Commission’s website. The initiative to revise the regulatory framework for medical devices was included in the Commission Work Programme 2012 COM(2011)777 final VOL. 1/2 and 2/2 as package on the innovation in health. The corresponding roadmap was made available here .
In 2005, the European Commission proposed amendments to Council Directives 90/385/EEC and 93/42/EEC which led to the adoption of Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007.