Notified Body Fees and Budgeting Under the EU MDR

1. Key takeaways

The MDR contains no EU-level fee schedule for product applications. The Union-level provision concerned with fees is Article 105, which addresses fee arrangements related to the designation and surveillance of notified bodies, to be determined by the Commission through implementing regulations; the actual cost of conformity assessment is charged by notified bodies under commercial pricing and is a practical estimate. Accordingly, any statement along the lines of an official EU application fee of X euros (EUR) lacks a legal basis. Budgeting must therefore be built from three distinct fee packages: notified body fees, the manufacturer’s own internal investment, and compliance service fees — the first priced commercially, the latter two priced by the market. Added to this is schedule uncertainty: the Commission proposal COM(2025) 1023 final notes that conformity assessment lacks predictable timelines, and timeline slippage itself generates cost. New implementing rules adopted in 2026 also change the depth of audits, so budget assumptions should be reviewed whenever the assessment framework moves.

2. Legal basis

The instruments relevant to fees and conformity assessment workload are set out below; note that none of them establishes a product application fee schedule.

3. Expert insights

Insight one: three fee packages must be kept apart in the cost structure.

In practice, the fee packages companies face usually fall into three blocks. The first is notified body fees: application, technical documentation review, quality system audits, surveillance audits and changes. The second is the manufacturer’s own investment: building the quality management system, preparing technical documentation, clinical evaluation, verification testing and the PRRC. The third is compliance service fees: EC REP, PRRC support, consulting and translation. The first block is commercial pricing; the latter two are market pricing; none of the three is an official rate (practical estimate). Keeping the three blocks separate matters because each behaves differently: notified body fees are quoted per project and can be negotiated, internal investment scales with portfolio size and documentation maturity, and service fees recur annually. A single blended number hides exactly the cost drivers a management team needs to see.

Insight two: the cost centre of gravity has shifted compared with the old directives.

Under the old directives, the cost weight leaned towards review and certification; under the MDR, the share of clinical evaluation, PMCF, technical documentation preparation, the SSCP, UDI and EUDAMED registration has risen markedly. Budgeting on the cost structure of an old-directive project will underestimate the internal investment (practical estimate). The practical implication is that internal staff time and documentation work now dominate the total cost of ownership for many portfolios, which means the budget owner must be the same person who controls documentation scope, or the two will drift apart and the estimate will lose touch with reality.

Insight three: timeline uncertainty is itself a cost, not merely a scheduling problem.

COM(2025) 1023 final (2025-12-16) states in its explanatory section that conformity assessment lacks predictable timelines and that practices differ across Member States, affecting the efficiency of obtaining CE marking. A stretched timeline directly pushes up the number of notified body surveillance audits, the cost of maintaining documentation and the opportunity cost. The budget should therefore carry an explicit buffer for timeline extension rather than treating the assessment calendar as fixed, and renewal projects should be started with the possibility of delay priced into the plan from the outset.

Insight four: the 2026 instrument (EU) 2026/977 changes the yardstick for audit depth.

Implementing Regulation (EU) 2026/977 (2026) establishes harmonised requirements for conformity assessment and notified bodies (Annex VII). Changes at the level of the detailed rules affect the review workload, and in turn the quotation structure and the project budget (practical estimate). Companies should ask their notified body how the harmonised requirements affect their review templates and audit durations, and update the budget assumptions accordingly rather than reusing last cycle’s quotations.

4. Practical recommendations

1. Split the budget by the three fee packages, and mark the pricing nature of each line item (commercial pricing / market pricing).
2. When requesting quotations from notified bodies, provide complete information (classification, route, whether software is included, whether an expert panel is needed, documentation maturity) to reduce quoting error.
3. Carry a dedicated buffer for timeline extension in the budget, since notified body capacity constraints are expressly flagged in the proposal.
4. Include internal investment (clinical evaluation, PMCF, PRRC, UDI, EUDAMED) in the project cost rather than hiding it in operating expenses.
5. Review periodically how (EU) 2026/977 affects the review workload and update the budget assumptions.

5. Verification checklist

Before submitting the budget for approval, confirm each of the following items.

• □ It is confirmed that the MDR has no EU-level product application fee schedule (Article 105 is the legal basis for notified-body-related fees)
• □ The budget is split by the three fee packages with the pricing nature marked
• □ The quotation request includes classification, route, software, expert panel and documentation maturity
• □ A dedicated buffer for timeline extension is included
• □ Internal investment (clinical evaluation, PMCF, PRRC, UDI, EUDAMED) is counted in the project cost
• □ The impact of (EU) 2026/977 on the budget assumptions has been reviewed

Regulatory information verified as of 29 October 2026.

GRZAN supports manufacturers budgeting for EU MDR market access, providing EU Authorised Representative (AR) and PRRC services as part of the compliance service fee package, guidance on structuring notified body quotations and internal investment lines, and fee and budget planning that accounts for timeline buffers and the effects of Implementing Regulation (EU) 2026/977. Our team helps companies without an establishment in the European Union present defensible, package-separated budgets under Regulation (EU) 2017/745. For practical support with authorisation, conformity assessment budgeting and compliance services, contact GRZAN at info@grzanglobal.com.