Article 50 of Regulation (EU) 2017/745 on Medical Devices (MDR) and Article 46 of
Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establish the
requirement for notified bodies to make their standard fees publicly available: “Notified
bodies shall establish lists of their standard fees for the conformity assessment
activities that they carry out and shall make those lists publicly available“. Neither the
MDR nor the IVDR do provide any definition of “standard fees” itself.
When setting their fees, Notified Bodies also need to consider Annex VII 1.2.8 of the
MDR and IVDR about their terms and conditions being fair and reasonable and taking
into account the interest of small and medium-sized enterprises as defined in
Recommendation 2003/361/EC…
