EU: Designation Process for Notified Bodies under the MDR
The NBOG – EU Notified Bodies Operations Group has just issued a best-practice guide on the designation and notification of conformity assessment bodies under the new Medical Device Regulation (MDR).
The document outlines the procedures and timelines for the designation and notification of Notified Bodies against the MDR and suggests that a Notified Body has to apply at least 18 months in advance of the relevant Directive being effective.
However, the guide suggests also that the designation of the first Notified Bodies under the new Directive is unlikely to be before July 26, 2019, even for Notified Bodies, which have already applied for a designation.
For the guideline please go here.