Medical Devices Directives may be revised

The European 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.

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