Theme | List of standard fees |
Target Audience | Notified bodies |
Products concerned | MD, IVD |
Regulatory reference | MDR (EU) 2017/745 IVDR (EU) 2017/746 |
Documents mentioned | MDCG 2019-6 Recommendation 2003/361/EC |
Regulations (EU) 2017/745 and 2017/746 require Notified Bodies to establish lists of their standard fees for the conformity assessment activities they perform and to make these lists publicly available.
The MDCG provides a template for a “Standard Fee List” and provides details on how these fees are established and made available to the public.