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Implementing the Future of Medical Devices

The 21st Meeting of Competent Authorities (CA) for Medical Devices under the Slovenian EU Presidency took place in Brdo on 25 and 26 February, 2008.

Following the revision of medical devices directives, CA's discussed several outstanding issues to be further clarified through guidelines and the required actions (e.g. meetings, trainings, publications) to be taken for proper implementation of Directive 2007/47/EC. Interface of the Medical Devices Directives with other legislation, particularly borderline issues were discussed and need for further clarification concerning interpretation of definitions was pointed out. The meeting also agreed that further consideration was needed on the new provisions on clinical investigations and software.

The consequence of the revision of the horizontal New Approach Directives for the Medical Devices Sector, particularly the future system of designation and supervision of Notified Bodies (NB) and market surveillance, were discussed in light of the need to guarantee a harmonized high level of performance of NB and high level of public health protection. The meeting agreed on the need to critically analyses the implications of the New approach regulation compared to the Medical Device Directive requirements.

The Meeting emphasized the need for information and best practice exchange between CA's that are of the crucial importance, and highlighted importance of communication between CA's and stakeholders, including international cooperation. Such an approach contributes to the safety of patients, proper quality of marketed products, high level of health protection, harmony of the internal market and free movement of devices.

Preliminary information on the study on distribution channels and MS's experience concerning counterfeit medical devices were presented. The study's objective was to provide initial data needed for further activities to combat counterfeit medical devices, to ensure safe medical devices in parallel trade and to explore the need for specific legal requirements based on assessment of social, economic, environmental and other relevant impact as well as to develop a strategy for further action.

CA's emphasized the need to permanently monitor and contribute to the development of new and emerging medical technologies in the light of the existing legal and regulatory framework.

The meeting renewed its commitment to the work of the Notified Body Operations Group and endorsed the groups work programme.

Finally the meeting adopted a revised market surveillance communication protocol plus rationales for agreeing new work items and closer working with other specialist working groups as well as endorsing the future work programme of the Compliance and Enforcement Working Group.


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Date: 03.03.2008