On November 7, 2017 the CAMD – Competent Authorities for Medical Devices – published the road map for the implementation of the new Regulation.
The document identified seven thematic areas and a generic priority as well as a specific working group was assigned to each one of them. In particular, priority activities highlighted by the CAMD include guidance for UDI assignments, guidance on requirements for vigilance reporting and guidance on the Notified Body designation process.
In this regard, on November 27, 2017, the first implementing act approved by the European Commission concerning medical device and IVD product codes became effective.
Product codes define the Notified Bodies scope and they should be included within their designation request so that manufacturers can verify their areas of application.
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