EU MDR certification cost calculator
CE marking: estimate Notified Body fees and implementation cost. This uses published fee schedules, then lets you add internal and external implementation costs. It is not legal or financial advice.
Calculator
Start with three inputs, then adjust advanced options if needed.
Advanced options
Run a pre-submission gap analysis on your Technical File and get gaps plus cited evidence in minutes.
- Fee schedule: BSI MDR fees (EUR, 2025 schedule)
- Device class: IIa
- Readiness: QMS running, evidence partial
- FTE in scope: 25
- TD review days (range): 4 to 6
- Audit days (heuristic range): 2 to 4
Toggle these if they apply. The range will update.
Methodology and sources
Summary of the baseline ranges and the sources behind them. Open to see the methodology details and links.
The Notified Body portion is estimated from published fee schedules. For example, BSI publishes MDR fees including an application fee, audit day rate, and technical documentation assessment day rate, plus typical day ranges for technical documentation review and clinical evaluation review.
You can switch fee schedules (BSI, TUV SUD, or your own custom rates) and adjust the assumed number of audit and review days. The goal is to turn unknown into a transparent model you can tweak to match quotes you receive.
Internal and consultant costs are added as optional line items because they vary widely by device novelty, evidence quality, and how much rework you do pre-submission. The calculator shows what typically drives costs and where teams lose time and money (incomplete files, unclear evidence, repeated corrective cycles).
BSI MDR Fees for Conformity Assessment Activities (EUR) (effective 1 Jan 2025): application fee, audit day rate, technical documentation assessment day rate, clinical evaluation assessment day rate, and typical day ranges for some reviews. BSI fee schedule (EUR)
TUV SUD MDR conformity assessment procedures page: published hourly rates for audits and technical documentation assessment, plus an application management fee per case. TUV SUD MDR procedures
European Commission document linking to published MDR fee pages across Notified Bodies. EC MDR NB fees index
List of standard fees transparency requirement (Notified Bodies shall publish standard fee lists). Article 46 standard fees
Team-NB Code of Conduct: auditor day is defined on an 8 hours/day basis (used for hourly to daily conversions).
How AI Gap Analysis reduces MDR cost risk
Notified Body rates are fixed. The variable is how many extra review days you trigger when your evidence is hard to verify.
AI Gap Analysis reads your Technical File and QMS PDFs and gives you evidence-linked answers with citations and deep links to exact pages, plus gaps and recommendations so you can fix issues before submission.
- Evidence with page links (show exactly where you meet a requirement)
- A clear gap list (what's missing or weak)
- Recommendations (what to fix next)
Reduce Notified Body rework before you submit
Upload your PDFs and get an evidence-ready gap report in minutes.
FAQ
What costs does this include?
It estimates Notified Body fees (application, audits, technical documentation review, and optional items) based on published fee schedules. It also lets you add internal effort, consultant effort, lab testing budget, and clinical investigation budget as optional inputs.
Why is it a range?
Public fee schedules publish rates and sometimes typical day ranges, but actual effort depends on file completeness, device complexity, and the audit scope.
Are these the same fees for every Notified Body?
No. Notified Bodies publish their own fees and structures. The EU Commission provides a document that links to fee pages across multiple Notified Bodies so you can cross-check and adapt the model.