[P] [B] Invitation for Public Comment [/B] [/P] [P] 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. [P] In line with the Commission’s policy on consultation, the Commission has prepared a public consultation [link] http://ec.europa.eu/enterprise/medical_devices/recast_docs_2008/Public_consultation_en.pdf(in the form of a questionnaire)[/link] 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:[/P] [UL] [LI] to what extent the Medical Devices Directives can be [B] improved [/B]; and [/LI] [LI] the [B] socio-economic impact [/B] of the changes envisaged and, in particular, the impact on the [B] protection of health and safety [/B] of patients, healthcare professionals or, where applicable, other users, on the [B] functioning of the internal market [/B] and on the [B] competitiveness[/B] of industry, including, in particular, small and medium sized enterprises.[/LI] [/UL] [P] 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. [/P] [P] Particular emphasis on the impacts, costs and savings to small and medium sized enterprises (SMEs) would be welcome.[/P] [P] 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. [/P] [P] 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: [/P] [P] European Commission [/P] [P] Unit ENTR F/3, Cosmetics and Medical Devices [/P] [P] BREY 10/176 [/P] [P] B-1049 Brussels [/P] [P] Belgium [/P] [P] Fax: + 32 2 296 64 67 [/P] [P] E-mail: ENTR-MD-RECAST@ec.europa.eu [/P] [P] [B] Background [/B] [/P] [P] 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. [/P] [P] 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. [/P] [P] This situation has motivated the Commission to consider the revision of this legal framework. [/P] [P] Note: individual contributions below - confidential contributions from:[/P] [P] Lithuania - Ministry of Health [/P] [P] Poland - Office for Registration of Medicinal [/P] Products, Medical Devices and Biocidal Products [/P] [P] Australia - Therapeutic Goods Administration [/P] [P] Canada - Health Canada / Santé Canada [/P] [P] Japan – Government of Japan [/P] [P] United States of America - Food and Drug Administration[/P] [P] Snitem – The French association of medical technology industry[/P] [P] Sony Deutschland GmbH[/P] [P] Alliance Boots[/P] [P] BD Technologies[/P] [P] Biomet UK Ltd[/P] [P] Boehringer Ingelheim GmbH[/P] [P] GlaxoSmithKline Services Unlimited[/P] [P] Kaltenbach & Voigt GmbH [/P] [P] Laboratoire Bongert [/P] [P] Operon sa[/P] [P] Smith and Nephew [/P] [P] Smith and Nephew Endoscopy [/P] [P] Toiletry Sales Ltd[/P] [P] Warren Solano [/P] [P] Zimmer Inc [/P] [P] Bernhard Lobmayr[/P] [P]Central Tissue Bank – Ghent University Hospital[/P] [P]Max Gros – Prothésiste (patients & consumers)[/P] [P]Nathalie Ygon (patients & consumers)[/P] [P]Raphael Brausch (patients & consumers)[/P] [P]Det Norske Veritas Certification AS[/P] [P]Lloyd’s Register Quality Insurance Ltd[/P] [P]UL Medical Notified Body/UL International ltd UK[/P] [P] For further information: [P]ENTR-COSM-MED-DEV@ec.europa.eu