Today the Medical Device Coordination Group released: MDCG 2023-2 – List of standard fees
The MDR/IVDR requires that Notified Bodies make their fees publicly available. The Medical Device Coordination Group further advised in MDCG 2019-6 that this “implies that a member of the public can access this information at any point in time, without the need for additional steps.”
However, as discussed in Casus’ recent post on Notified Body Fees and Capacity, there is still a lack of public data available.
MDCG 2023-2 aims to create more transparency. It reiterates that fees should be directly and easily accessible on the Notified Body’s website, and manufacturers should not have to register or provide contact data in order to understand the fees.
The MDCG provides a table of how Notified Bodies can present their fees. Examples of items included are:
- Confirmation if fees are flat, hourly, or daily
- Factors influencing the calculation of the fee charged
- Fee range (min-max)
- Travel-time costs, if applicable
- Administrative costs, such as travel expenses
- Initial, surveillance, unannounced and recertification audits
- Clinical evaluation report assessments
- Evaluation/review of Periodic Safety Update Reports (PSURs)
- The Notified Body’s policy regarding pricing for small-to-medium-size enterprises (SMEs)
MDCG 2023-2 is not intended to inform Notified Bodies of what fees they should charge. Notified Bodies can decide how to price their services, and the scope (e.g., number of hours/days) needed in order to adequately assess conformity. Instead, it simply outlines a best practice of how to present the information so that the public can make an informed decision.
The question then becomes: When will Notified Bodies publish their fees?
Well, first, MDCG guidance documents are not legally binding. That said, as a standard rule Notified Bodies generally adhere to MDCG guidance as it is considered best practice. Per Team Notified Body’s September 2022 Position Paper, Notified Bodies will take up to 12 months from MDCG guidance publication for roll-out of changes. Possibly we will see a few Notified Bodies take the leap to comply with fee transparency, thereby applying peer pressure for other Notified Bodies to follow.