EU: (Re-)Designation process for notified bodies means bottleneck for medical devices manufacturers
The AG MPG (Working Group of Industrial Associations for the German Medical Devices Act) has created a document on the (re-)designation process for notified bodies.
In this paper the AG MPG asks the national and European legislators for a faster process for the (re-)designation of notified bodies, so that new products can be placed on the market without delay and existing and well-established products remain available for patients. The legislator is called upon to bring the bottleneck in the (re-)designation of notified bodies in such a shape that enough time is given for manufacturers to have their products tested and certified by notified bodies.
You can find the document here: AG MPG Bottle Neck designation of Notified Bodies.