The large number of directives regulating the medical devices market has prodded the European Commission to set in motion a consultation process, running between 8 May and 2 July, to simplify the nine EU directives that have given relevance to the existing legislation in this area since 1990. These directives, however, had been criticised as being rather complicated and fragmented. Besides, EU Member States have been implementing these directives at different levels.

By 2005, in its Communication entitled Implementing the Comm-

unity Lisbon Programme: A Strategy for the simplification of the regulatory environment, the Commission had already pursued the simplification of the Directives related to medical devices, implantable medical devices and blood derivatives, and pushed for a high level of security in public health.

The current system in Europe shows that it does not offer a consistent level of protection for public health in the European Union. Take for example the new and emerging technologies. These, in fact, have accentuated gaps in the system and pointed to a certain deficiency of expertise.

Also, the European Community has to converge on the global model if it wants to keep the European industry competitive. As for the legal system, criticism has focused on its being too fragmented, difficult to follow and riddled with national variations.

The said consultation exercise targets the same level of treatment for both patients and health professionals when it comes to assessing effects on health and safety standards and to deal with the growing expectations of European citizens. The Commission has prepared a public consultation in the form of a questionnaire. The respondents’ comments will be studied thoroughly to evaluate the extent to which the Medical Devices Directive could be improved and the socio-economic impact of the changes envisaged.

Expectedly, their answers include data corresponding to these different aspects. An evaluation of actual and estimated costs, as well as other relevant quantitative figures, should also be submitted where possible. Impacts, costs and savings to Small and Medium Enterprises are also given particular emphasis. The Commission also pledges the confidentiality of the respondents’ submissions, if so indicated by them.

Europe accounts for a third of the global medical devices market. EU Commissioner for Enterprise and Industry Gunter Verheugen, stresses the fact that the proposed simplification of the existing legislation is crucial to maintain the right conditions for innovation and competitiveness in the medical device industry.

Along with the Commission, the European Medical Devices Association and an important stakeholder, Eucomed were involved in the discussions and willingly accepted the proposal for a public consultation on the proposed Directive.

Eucomed comprises, directly or indirectly, more than 4000 designers, manufacturers and suppliers of medical technology used in the diagnosis, prevention, treatment and amelioration of disease and disability. According to John Wilkinson, director general of Eucomed, Eucomed suggests that the basic principles of the new approach are maintained and that all the new devices are subject to the next Medical Devices Directive.

By the end of next year, new legislation is expected to be introduced on the basis of the outcome of the questionnaire.

For further information you may contact Forum Malta fl-Ewropa on 2590-9101 or email on [email protected]

Brenda Azzopardi is Research Analyst at Forum Malta fl-Ewropa