Revision of the medical device directives

Revision of the Medical Devices Directives: 2008 - onwards

The Commission is considering a revision of the legal framework  français (fr) for Medical Devices in order to improve and strengthen this framework and to meet the growing expectations of European citizens since the last technical revision brought about by Directive 2007/47/EC.

Experience indicates that the current system does not always offer a uniform level of protection of public health in the European Union. New and emerging technologies have challenged the current framework, highlighting gaps and pointing to a certain scarcity of expertise. In addition, in recognition that the medical devices market is a global one, to keep European industry competitive, the Community regime needs to further converge on the 'global model'. And finally, the legal system has been criticised as being too fragmented and difficult to follow and fraught with national variation.

This situation has motivated the Commission to consider the revision of this legal framework.

See the roadmap 2012 (35 KB)

1. Public consultation on the medical devices directives recast:

Between 8 May and 2 July 2008, the European Commission services consulted stakeholders on the revision of the legal framework for medical devices ("recast").

Results

• summary report of the consultation results(63 KB)
• individual responses

Questionnaire

• Questionnaire form(77 KB)

2.  Public consultation on technical aspects of the revision of the In Vitro Diagnostic medical device Directive

In the context of the recast of the regulatory framework for medical devices and following the consultation mentioned above, the European Commission has launched a public consultation on technical aspects related to the revision of Directive 98/79/EC on in vitro diagnostic (IVD) medical devices. It invites stakeholders to provide feedback with regard to the proposed options. The current legislation was adopted in 1998. Since then IVDs have significantly evolved technologically. Also the broader regulatory landscape has changed in Europe and at international level. The Commission considers it necessary, to introduce (interalia) clearer definitions and requirements for safety and performance. This concerns in particular tests which are made and used within the same health institution ("in house tests"), genetic tests or diagnostic services.

Results

• summary report of the consultation results(160 KB) 
• individual responses

Questionnaire

• Questionnaire form(58 KB)  Deutsch (de) français (fr)  

Related documents

• Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (AIMD) [158 KB]
• Directive 93/42/EEC concerning medical devices (MDD) [265 KB]
• Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) [188 KB]
• COM(2005) 535 Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment [318 KB]

 

Revision of the Medical Device Directives: 2004-2007

The European Commission has proposed amendments to the legislative framework of the medical devices sector. The proposal has been developed involving extensive stakeholder consultation and has also been subject to a public consultation. The public web consultation on the proposal was closed on the 25 June 2005. This brought forward many relevant and important contributions which, where appropriate, were incorporated into the proposal. The most significant proposals concern conformity assessment, including design documentation and design review, clarification of the clinical evaluation requirements, post market surveillance, compliance of custom-made device manufacturers and the alignment of the original medical device directive 90/385/EEC.

Results

The Commission Services received, and responded to, over 80 written submissions, resulting in over 300 specific comments, from a variety of stakeholders, but primarily from industry, trade associations, consultants and national authorities; a small number of individuals and patient groups also responded. Geographically most submissions came from the European Union, with others from Switzerland, USA, Australia and Japan.

• Summary report on the responses to the consultation(14 KB)

Background

The Consultation was based on the following documents:

• A text(356 KB) highlighting the changes as they would appear in the current text of Directive 93/42/EEC.
• In line with the Communication(281 KB) presented to the Council and Parliament in the summer of 2003 the Commission services, together with stakeholders, has prepared an early draft text to amend the Medical Devices Directive 93/42/EEC.

Related documents

• 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.(189 KB)
• 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.(128 KB)
• Impact Assessment(76 KB)