ASN and AFSSAPS make recommendations for increase of requirements on radiotherapy medical devices

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Two serious incidents in 2006 and 2007 led the French authorities to implement a series of measures to strengthen the security of the practice of external radiotherapy.

In line with these measures, ASN and AFSSAPS have committed a specific reflection on the relationship between the radiation protection requirements of the Directive 97/43/Euratom and IAEA recommendations to the essential requirements of Directive 93/42/EEC applicable to devices including external radiotherapy linear accelerators of electrons.

This reflection was conducted in an ad hoc working group composed of experts in these matters, representatives of users, a representative of the French office of standardization in the Electrotechnical sector and representatives of the competent Belgian, Swiss and French.

This group produced a report presenting an analysis of the European regulatory framework and international requirements for medical devices used in radiotherapy. In addition, this document contains recommendations for increase the measures to affix the CE marking on these facilities and to complete the project of Euratom Directive on aspects of risk analysis and reporting of significant events.

ASN and AFSSAPS submitted this work to the European Commission and wish defend these recommendations at European level.