Revision of the medical device directives

Ongoing revision

First reading vote of the European Parliament

Amendments for Medical Devices
Amendments for IVD's

Commission position on the European Parliament amendments

Medical Devices : Commission response to text adopted in plenary
IVD's: Commission response to text adopted in plenary

Proposals of the European Commission

On 26 September 2012, the European Commission adopted a package on innovation in health consisting of

The adoption of the above documents was announced in a press releasepdf(70 KB). The key elements of the revision are summarised in a Citizens' Summarypdf(37 KB) and in a questions and answerspdf(79 KB) document.

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.

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.

Public Consultation

On 8 May 2008, the European Commission published a public consultation document pdf(77 KB)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 pdf(63 KB) 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 herepdf(49 KB) Choose translations of the previous link Deutsch (de) français (fr) . The summary report pdf(160 KB) 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. 1/2pdfand 2/2pdfas package on the innovation in health. The corresponding roadmap was made available herepdf

Previous revision

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.

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