What does it mean to have a quality system under Module D/D1?

Module D refers to a quality assurance system for ensuring conformity with EU product regulations, such as the EU Fertilising Products Regulation (FPR) or various directives including the Machinery Directive or Medical Devices Regulation. It is one of several modules outlined in the New Legislative Framework (NLF) for assessing product conformity.

In essence you show that you have a quality system, under supervision of a Notified Body, that proves you can fulfill the requirements set by the regulation. In cases of Module D1 it also means you have a system that allows you to design products and place them onto the market. De facto you become your own Notified Body under the supervision of an existing Notified Body as you can design and put new products onto the market. For this you must thus also have procedures as such.