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Revision of the medical device directives
Proposals of the European Commission
On 26 September 2012, the European Commission adopted a package on innovation in health consisting of
- the Communication on safe, effective and innovative medical devices and in vitro diagnostic medical devices for the benefit of patients, consumers and healthcare professionals
- the Proposal for a Regulation of the European Parliament and of the Council on medical devices, and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009
- the Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices
The Commission proposals are accompanied by an impact assessment on the revision of the regulatory framework for medical devices that consists of
- an Executive Summary of the impact assessment ,
- Part I of the impact assessment addressing the systemic problems (e.g. oversight of Notified Bodies, post-market safety, transparency, governance) that are of a horizontal nature and apply to medical devices and in vitro diagnostic medical devices (IVDs) alike,
- Part II – Annex 1 that addresses specific issues relevant for medical devices other than IVDs [link] and Part II – Annex 2 that addresses specific issues relevant for IVDs,
- Part III – Appendices that contains supporting documents.
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.
Preparation of the European Commission's proposals
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. 1/2and 2/2as 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.
- Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
- Proposal for a Directive of the European Parliament and of the Council amending Council Directives 90/385/EEC and 93/42/EEC and Directive 98/8/EC of the European Parliament and the Council as regards the review of the medical device directives.
- Impact Assessment
- Summary report on the responses to the consultation
- A public consultation text highlighting the changes as they would appear in the current text of Directive 93/42/EEC
- Communication of 2 July 2003 from the Commission to the Council and the European Parliament on medical devices