European
Compliance Platform
European
Compliance Platform
External-budget planning ranges by device class, with current EU sources for Notified Body fees, EUDAMED, and quotation rules.
There is no official EU-wide total price for CE marking. For external-budget planning in 2026, indicative project ranges are Class I: €8,000–€26,000; Class Is/Im/Ir: €15,000–€50,000; Class IIa: €32,000–€110,000; Class IIb: €70,000–€220,000; Class III: €200,000–€600,000+. These are planning scenarios, not regulator-set fees. The budget changes materially with device complexity, existing evidence, number of sites and device families, documentation readiness, and whether clinical investigation is needed.
| Device Class | Total Range | Main Cost Drivers |
|---|---|---|
| Class I (self-certified) |
€8k–€26k | No Notified Body for a standard Class I device. Main work: MDR QMS, technical documentation, testing where applicable, clinical evaluation, UDI and EUDAMED. Add an EU Authorised Representative only for a non-EU manufacturer. |
| Class Is/Im/Ir (sterile/measuring/reusable) |
€15k–€50k | Notified Body involvement is limited to sterility, metrology or reusable-instrument reprocessing aspects, plus QMS, technical documentation and testing. Add an EU AR only for a non-EU manufacturer. |
| Class IIa | €32k–€110k | QMS and sampled technical-documentation assessment, clinical evaluation, testing, UDI/EUDAMED and possible external regulatory support. |
| Class IIb | €70k–€220k | QMS audit, technical-documentation sampling, deeper clinical assessment, testing, possible consultation procedures and additional review cycles. |
| Class III | €200k–€600k+ | Full QMS and technical-documentation assessment, extensive clinical evidence, testing and PMCF. A clinical investigation can dominate the budget when existing evidence is insufficient. |
~ PLANNING ESTIMATE The totals model external services and third-party assessment; they exclude internal staff time, VAT, travel, remediation after nonconformities and commercial launch costs. EU AR cost is excluded unless the manufacturer is established outside the EU. No EU regulator publishes total project prices, so obtain an itemised quote for a decision-grade budget.
MDR Article 50 requires each Notified Body to establish and publicly disclose its standard fees. On 13 July 2026, the European Commission updated its central directory, which links to fee schedules for 52 MDR Notified Bodies. The directory is current, but the linked tariff documents have different publication dates and billing structures. A published hourly rate is therefore not a total certification price.
| Official source | Published fee information | Edition shown in EC directory |
|---|---|---|
| European Commission MDR fee directory | Links to public standard-fee pages for 52 MDR Notified Bodies; use the NB number to identify the exact legal entity. | Updated 13 July 2026 |
| TÜV SÜD Product Service, NB 0123 | QMS audit €320/hour; technical-documentation assessment €430/hour; clinical assessment €430/hour; application management €2,550/case. | Current document linked by EC |
| TÜV SÜD Danmark, NB 2443 | QMS audit €320/hour; technical and clinical assessment €430/hour; application management €2,550; annual maintenance €2,550. | Current document linked by EC |
| NSAI, NB 0050 | The Commission links to NSAI's complete MDR price list; check the document itself before budgeting. | Price list labelled 2024 |
| SGS Fimko, NB 0598 | The Commission links to SGS Fimko's complete MDR standard-fee schedule. | Price list labelled 2024 |
| Intertek Medical, NB 2862 | The Commission links to Intertek Sweden's complete MDR standard-fee schedule. | Standard fees labelled 2025 |
✓ OFFICIAL SOURCES Checked 20 August 2026 against the European Commission directory and the linked Notified Body publications. Rates can change and may exclude travel, accommodation, VAT, subcontracted experts, extra review cycles and special procedures.
A cross-NB average has deliberately not been calculated: fee schedules use different units, minimum charges and inclusions, so a simple average can be misleading. Compare the estimated total hours and all fixed/additional charges in the quotation, not just one headline hourly rate.
| Cost component | Budget treatment | What to include |
|---|---|---|
| Notified Body assessment | Individual itemised quote | Application, QMS audit, technical and clinical review, certification, surveillance, travel and possible extra cycles. There is no official universal project range. |
| MDR QMS / ISO 13485 support | €7k–€69k ~ EST. | Gap assessment, implementation support and, where chosen or required by the conformity route, third-party certification. MDR requires an appropriate QMS; a separate ISO 13485 certificate is not automatically required for every self-declared Class I device. |
| Testing (EMC, electrical, biocompat.) | €5k–€80k ~ EST. | IEC 60601-1 electrical safety ~€5k; IEC 60601-1-2 EMC ~€3.5k; full bundle €9k–18k; biocompatibility for implantables €15k–80k+. |
| Clinical Evaluation Report (CER) | €15k–€50k ~ EST. | Clinical evaluation is required for every device; cost depends on available data, equivalence strategy, literature volume and identified evidence gaps. |
| Clinical investigation, where required | €100k–€500k+ ~ EST. | Often a major driver for novel and high-risk devices when existing clinical evidence is insufficient. It is not an automatic cost for every project. |
| EU Authorised Representative | €3k–€15k/yr ~ EST. | Required only when the manufacturer is established outside the EU. Scope and liability vary by class and portfolio. |
| EUDAMED registration + UDI | No EU EUDAMED fee; service costs vary | Actor and device registration work, Basic UDI-DI/UDI issuer costs and record maintenance. Do not present consultant or UDI-issuer charges as a European Commission registration fee. |
| Regulatory consulting | €10k–€100k ~ EST. | Technical file preparation, classification, conformity assessment strategy. Scales with class. |
All euro ranges in this component table are non-official planning estimates. Only fees linked to an identified Notified Body publication should be treated as published tariff data.
CE marking is not a one-time cost, but there is no official universal annual range. Build an annual budget from the applicable items: Notified Body surveillance and certificate maintenance; QMS surveillance; post-market surveillance and PMCF; PSUR preparation for Class IIa, IIb and III devices; vigilance and EUDAMED record maintenance; periodic testing or clinical follow-up; insurance; and an EU Authorised Representative retainer only for a non-EU manufacturer. Ask the NB to separate initial assessment, recurring surveillance and event-driven charges.
There is no regulator-set total. For an early external-services budget, use approximately €8,000–€26,000 for standard Class I, €15,000–€50,000 for Class Is/Im/Ir, €32,000–€110,000 for Class IIa, €70,000–€220,000 for Class IIb and €200,000–€600,000+ for Class III. These are planning scenarios, not quotes, and exclude internal staff time, VAT and remediation.
Article 50 requires public standard fees, but each schedule has different inclusions and units. The Commission's 13 July 2026 directory links to 52 MDR fee schedules. One current example is TÜV SÜD Product Service NB 0123: €320/hour for QMS audit work, €430/hour for technical-documentation or clinical assessment and €2,550 per application. Your total depends on hours, sites, device families and review cycles.
Class III projects require full QMS and technical-documentation assessment and usually more extensive clinical evidence and testing. A clinical investigation can dominate the budget where existing evidence is insufficient. The Article 54 expert-panel consultation applies only to specified Class III implantable and Class IIb active devices and has exemptions; it is not automatic for every Class III device.
There is no official universal annual range. Obtain separate figures for NB surveillance and certificate maintenance, QMS audits, PMS/PMCF, PSUR work for Class IIa and above, vigilance, EUDAMED maintenance, insurance and event-driven reviews. Include an EU AR retainer only when the manufacturer is outside the EU.
A standard Class I device that is non-sterile, non-measuring and not a reusable surgical instrument is self-declared and has no NB conformity-assessment fee. Class Is, Im and Ir require limited NB involvement for the relevant aspect. All manufacturers still need an MDR-compliant QMS, technical documentation and clinical evaluation; an EU AR is required only for a non-EU manufacturer.
Request an itemised Notified Body quotation
From 25 February 2027, IR 2026/977 requires quotations for new covered agreements to include specified cost categories, typical surveillance and possible additional charges, and estimated timelines. It does not impose one EU-wide quotation template or price. Submit your device scope on ECP so relevant Notified Bodies can prepare comparable proposals.
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