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.
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