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Revision of the legal framework for medical devices

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Deadline: 02/07/2008

Recast of the Medical Devices Directives - Results of Public Consultation <br/><br/> Between 8 May and 2 July 2008 the European Commission services consulted stakeholders on the revision of the legal framework for medical devices.

Invitation for Public Comment

The Commission is considering a revision of the legal framework in Europe for Medical Devices in order to improve and strengthen this framework and to meet the growing expectations of European citizens.

In line with the Commission’s policy on consultation, the Commission has prepared a public consultation in the form of a questionnaire in which stakeholders are invited to comment on the main issues. The responses to this consultation are going to be carefully studied by the Commission services to assess:

  • to what extent the Medical Devices Directives can be improved ; and
  • the socio-economic impact of the changes envisaged and, in particular, the impact on the protection of health and safety of patients, healthcare professionals or, where applicable, other users, on the functioning of the internal market and on the competitiveness of industry, including, in particular, small and medium sized enterprises.

Therefore to the greatest extent possible, respondents should include in their answers data corresponding to these different aspects (social and economic data), supported, where possible, by an evaluation of actual or estimated costs (expressed in figures such as cost per device, cost per manufacturer, cost per national authority, cost per hour, cost per man-day etc.), and by other relevant quantitative figures.

Particular emphasis on the impacts, costs and savings to small and medium sized enterprises (SMEs) would be welcome.

Submissions will be published on the “medical devices” website of the European Commission. Respondents should indicate whether they wish the Commission to treat their submission as confidential by indicating the word “confidential” on the first page of the contribution.

Any comments and information on this public consultation should be submitted by mail, fax or e-mail by Wednesday evening, 2nd July 2008, at the latest, to:

European Commission

Unit ENTR F/3, Cosmetics and Medical Devices

BREY 10/176

B-1049 Brussels


Fax: + 32 2 296 64 67



The Commission, in its Communication to the European Parliament and Council, “Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment”, COM(2005) 535, committed itself to simplify the Directives 90/385/EEC on active implantable medical devices and 93/42/EEC on medical devices as well as the blood derivatives Directives 2000/70/EC and 2001/104/EC. However, since 2005, a number of drivers have come into play that necessitates not only a simplification of these four texts but also a strengthening of the whole legal framework to give as high a level of protection of public health as possible.

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.

Note: individual contributions below - confidential contributions from:

Lithuania - Ministry of Health

Poland - Office for Registration of Medicinal

Products, Medical Devices and Biocidal Products

Australia - Therapeutic Goods Administration

Canada - Health Canada / Santé Canada

Japan – Government of Japan

United States of America - Food and Drug Administration

Snitem – The French association of medical technology industry

Sony Deutschland GmbH

Alliance Boots

BD Technologies

Biomet UK Ltd

Boehringer Ingelheim GmbH

GlaxoSmithKline Services Unlimited

Kaltenbach & Voigt GmbH

Laboratoire Bongert

Operon sa

Smith and Nephew

Smith and Nephew Endoscopy

Toiletry Sales Ltd

Warren Solano

Zimmer Inc

Bernhard Lobmayr

Central Tissue Bank – Ghent University Hospital

Max Gros – Prothésiste (patients & consumers)

Nathalie Ygon (patients & consumers)

Raphael Brausch (patients & consumers)

Det Norske Veritas Certification AS

Lloyd’s Register Quality Insurance Ltd

UL Medical Notified Body/UL International ltd UK

For further information:

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