Notified Bodies assist manufacturers in the conformity assessment of certain medical devices before being placed on the EU market. According to Article 50 of the Medical Devices Regulation (MDR) and Article 46 of the In Vitro Diagnostic Medical Devices (IVDR), Notified Bodies (NBs) have to establish lists of their standard fees for conformity assessment activities and make them publicly available.
In January 2023, the Medical Device Coordination Group (MDCG) published a document about the list of Notified Bodies’ standard fees and related templates (MDCG 2023-2).
Publication of fees and language requirements
In a previous publication (MDCG 2019-6), the MDCG clarified the meaning of “publicly available”. Precisely, “publicly available” implies that this information can be accessed at any time without requiring additional steps, e.g., a registration. The public must be able to find the list of fees on the website of the Notified Body in a direct, transparent, and easy way. Additionally, the NB website has to be displayed on NANDO, the European Commission website listing Notified Bodies.
The currency of the fees has to be the currency of the country where the Notified Body is located. The list should also include any regional differences in the pricing.
The language(s) of the list of fees must be in the website’s language(s).
Templates for “List of Standard Fees”
The templates provided in this new MDCG document should assist Notified Bodies in the publication of the list. Specifically, the list should cover all activities corresponding to the scope of the NB designation and their conformity assessment activities.
Notified Bodies can charge fees as:
- “Flat fees”, which are fixed fees that do not depend on the time and resources spent on the activity.
- “Time-based fees”, which are fees based on the time spent on the activity.
The fees have to include any type of expenses, such as external costs due to travelling or external testing. In case factors other than time include the fees, it is possible to present the expected fees as a range. Typically, presenting a rough estimation of the overall costs is necessary. The quotation and fees can vary significantly for individual devices within the same project. In such cases, NBs should inform manufacturers about such differences and justify them.
Additionally, Notified Bodies should describe how they take into account the interests of small and medium-sized enterprises (Recommendation 2003/361/EC).
The templates provided are:
- List of Standard Fees for Conformity Assessment Activities under the MDR (2017/745)
- List of Standard Fees for Conformity Assessments Activities under the IVDR (2017/746)
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