By Stewart Eisenhart, Emergo Group
Although the first Notified Bodies (NBs) will soon be designated to the European Medical Devices Regulation (EU) 2017/745 (MDR), the New Approach Notified and Designation Organisations (NANDO) database has been updated with a new NB for the current Medical Devices Directive 93/42/EEC, Active Implantable Medical Device Directive 90/385/EEC and In Vitro Diagnostic Medical Devices Directive 98/79/EC. BSI has now two NBs, each with its own NB number. The designation of an NB in The Netherlands is a relief for manufacturers currently certified by UK- based NBs, as CE Mark certificates may become void as a result of a Cliff-edge Brexit.
Get the full story here at the Emergo Group’s blog.
The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.
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