EU Central Management Committee weighs in on regulation of notified bodies
This article was originally published in RAJ Devices
The Central Management Committee of medical device regulatory experts from each EU member state that was established last year under the Belgian presidency to improve consistency in the interpretation and implementation of the medical devices legislation is taking a firm stand on tackling notified body issues.
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Eighteen years of free trade threatens to come to a sudden stop, as a result of the stalemate in the market access agreement between Switzerland and the EU. Industry association Swiss Medtech is advising local medtech manufacturers to find notified bodies and authorized representatives based in the EU. However, local company SQS remains confident of its ongoing notified body role.
The last year of the run up to the full implementation of the MDR has been characterized by a flurry of new documents and measures, but industry is adamant that medtech is heading for a crisis that will impact industry and patients alike.