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German reclassification not addressed in review:

This article was originally published in Clinica

Executive Summary

Proposals from the German medical device regulatory authority to review the classification of a series of products over which it has safety concerns are not going to be addressed in the context of the review of the Medical Devices Directive (see Clinica No 1125, p 2). That became clear during the meeting between the European Commission and the competent authorities on November 9 and 10. But interestingly, it was the not the Commission but rather other member states who impressed on the Germans the need to use tools already available in the Directive to make a formal request for such changes, namely Article 9, Classification and Article 13, Decisions with regard to classification, derogation clause. There is the intention to expand both these articles in the context of the review for clarification purposes, but there is nothing to prevent an application through these articles now.

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