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The EU Commission published a consolidated list of where to find each Notified Body’s public fee schedule. It is available here.
The list includes all 49 Notified Bodies designated under the MDR and all 12 Notified Bodies designated under the IVDR.
Fee transparency is required per MDR Article 50 / IVDR Article 46:
“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.”
While the above fee schedules are useful — it allows the user to get a sense of the Notified Body’s daily/hourly rate differences — it does not provide a holistic view of the full costs to CE Mark a device. Most of the fee schedules have caveats that the total number of days/hours will be determined by the type of device and size of organization.
Estimating Notified Body Fees
Despite the Notified Body fee transparency requirements, it is challenging for manufacturers to estimate the cost to obtain CE certification. This is without even considering ongoing fees to maintain certification, such surveillance audits and unannounced audits.
Notified Bodies generally only provide their flat, hourly, and daily rates, along with the factors that influence the final fee calculation (such as: location of the manufacturer, conformity assessment type, and maturity of the QMS). For example, BSI does this in its pricing schedules for MDR and IVDR conformity assessment activities for 2024.
This information does help manufacturers understand the reasons why fees may be higher than expected. However, providing the hourly/daily rate information without an indication of an average, or range, of hours/days needed (as most Notified Bodies do), prevents manufacturers from estimating the complete costs to enter the market.
Example Scenario
Below we provide a range generally experienced for a medium low-risk device manufacturer, under the following parameters:
- Manufacturer Size: Small*
- MDR: Class IIa
- IVDR: Class B, non-self-testing, non-near-patient testing
- Conformity assessment route: Annex IX – Chapters I, III (QMS) + Chapter III (Technical Documentation Assessment)
*A small company is defined as comprising 10 – 49 employees per the OECD definition of a small enterprise.
Under this scenario, a manufacturer can typically expect the following durations for initial CE certification:
- QMS Audit = 2-3 days
- Technical Documentation Assessment (including Clinical / Performance Evaluation) = 5-8 days
So, if a Notified Body’s daily rate for 1) Audits is listed as €3,000, then you can estimate €6,000-€9,000, and 2) Documentation Review is listed as €4,000, then you can estimate €20,000-€32,000.
Please note that the above does not include several other Notified Body fees that are part of the initial conformity assessment procedure. These are typically quoted as either flat fees or are dependent upon the manufacturer’s location and auditor proximity. For example:
- Administrative charges, e.g., application fees
- Travel costs, e.g., travel time, travel expenses (airfare/hotel expenses)
It also does not consider ongoing (Y2+) costs, such as:
- Annual surveillance audits
- Unannounced audits
- Change assessments, if applicable
The above fees are applicable once the finished device is ready to enter the market. By this point, the manufacturer will have assumed other costs, e.g., testing and consulting support, if QMS or technical documentation development is outsourced.
