European
Compliance Platform
European
Compliance Platform
Real cost ranges by device class — Notified Body fees, testing, consulting, and total budgets for MDR certification in 2026.
CE marking cost for a medical device under MDR depends primarily on risk class. Class I (self-certified): €8,000–€26,000. Class IIa: €32,000–€110,000. Class IIb: €70,000–€220,000. Class III: €200,000–€600,000+. Notified Body fees are published under MDR Article 50 — averaging around €317–€325 per hour for review and audit work, with application fees averaging €1,540. The largest cost driver for higher classes is clinical evidence, not the Notified Body fee itself.
| Device Class | Total Range | Main Cost Drivers |
|---|---|---|
| Class I (self-certified) |
€8k–€26k | No Notified Body. QMS setup €5k–15k, technical documentation €2k–5k, EU Authorised Representative €3k–8k, EUDAMED €0.5k–1.5k |
| Class Is/Im/Ir (sterile/measuring/reusable) |
€15k–€50k | NB for specific aspect only €10k–30k, plus QMS, technical documentation, and AR |
| Class IIa | €32k–€110k | NB €15k–50k; ISO 13485 €10k–30k; technical doc + CER €10k–30k; testing €5k–30k; consulting €10k–40k |
| Class IIb | €70k–€220k | NB €25k–100k; ISO 13485 €15k–40k; technical doc + CER €15k–50k; clinical evaluation €15k–40k; testing €10k–50k; consulting €20k–80k |
| Class III | €200k–€600k+ | NB €50k–250k; clinical investigation €100k–500k; technical doc + CER €20k–80k; testing €20k–80k; consulting €30k–100k; + PMCF and insurance |
~ ESTIMATED Total per-class ranges are industry-aggregate estimates (source: MedDeviceGuide 2026 breakdown, cross-checked against i3cglobal). No Notified Body publishes total project costs — only unit rates. Use these as planning ranges, not quotes.
Under MDR Article 50, every Notified Body must publish its standard fees. These are the only hard, verifiable cost figures available. The table below shows published hourly rates and fixed fees for selected NBs:
| Notified Body | Tech File Review | Clinical Review | QMS Audit | Certificate Fee |
|---|---|---|---|---|
| DQS | €250/hr | €250/hr | €250/hr | €4,000 |
| MEDCERT | €250/hr | €225/hr | — | €6,100 |
| GMED (0459) | €278/hr | €361/hr | €278/hr | — |
| TÜV NORD CERT | €369/hr | €262/hr | — | €8,925 |
| DNV | €373/hr | €285/hr | — | €8,400 |
| NSAI (0050) | €375/hr | €375/hr | €275/hr | €1,300 |
| SGS Fimko | €400/hr | €320/hr | — | — |
| BSI | €420/hr | €245/hr | — | €6,450 |
| TÜV SÜD (0123) | €430/hr | €430/hr | €440/hr | — |
| Intertek | €396/hr | €545/hr | €495/hr | — |
| Istituto Superiore di Sanità | €925/hr | €412/hr | €553/hr | €8,500 |
✓ VERIFIED Source: Qualitiso comparison of Notified Body fees, compiled from each NB's published MDR Article 50 fee schedule. Rates as published; subject to change.
✓ VERIFIED Aggregate averages — Qualitiso / RookQS dataset. Premium NBs (e.g. specialist fast-track providers) charge €650–€1,100/hr ~ EST.
| Cost Component | Typical Range | What It Covers |
|---|---|---|
| Notified Body assessment | €15k–€250k | QMS audit + technical documentation review, billed at published hourly rates. Scales with class and device complexity. |
| ISO 13485 (QMS) implementation | €7k–€69k | QMS setup and certification body audit. Western Europe small single-site audit: €7k–13k; full consultant implementation: up to €69k. |
| Testing (EMC, electrical, biocompat.) | €5k–€80k | 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 | Literature-based CER authoring for lower-risk devices. For Class IIb/III with clinical data generation, costs rise substantially. |
| Clinical investigation (Class III) | €100k–€500k | Where required for Class III or novel devices. The single largest cost driver for high-risk devices. |
| EU Authorised Representative | €3k–€15k/yr | Required for non-EU manufacturers. Annual retainer scales by class and product portfolio. |
| EUDAMED registration + UDI | €0.5k–€5k | SRN registration, Basic UDI-DI assignment, device record creation. Higher classes require more setup. |
| Regulatory consulting | €10k–€100k | Technical file preparation, classification, conformity assessment strategy. Scales with class. |
✓ VERIFIED for NB rates and ISO 13485 audit fees; ~ ESTIMATED for testing, CER, clinical, and consulting ranges (consultancy aggregates — actual quotes vary by device).
CE marking is not a one-time cost. Ongoing annual compliance ranges from approximately €29,000 to €160,000+ depending on class, including: Notified Body surveillance audits (€5k–25k), annual certificate maintenance (€500–10,600), EU Authorised Representative retainer (€3k–15k), post-market surveillance and PSUR preparation, EUDAMED maintenance, ISO 13485 surveillance audits, and — for Class III — product liability insurance (€3k–7k).
CE marking cost depends primarily on risk class: Class I (self-certified) €8,000–€26,000; Class IIa €32,000–€110,000; Class IIb €70,000–€220,000; Class III €200,000–€600,000+. Notified Body hourly rates are published under MDR Article 50, averaging €317–€325/hour with application fees averaging €1,540. The largest cost driver for higher classes is clinical evidence, not the NB fee itself.
NBs publish fees under MDR Article 50. Technical file review hourly rates range from €200 (Berlin Cert) to €925 (Istituto Superiore di Sanità), with most between €250–€430/hour. Average across 20+ NBs: ~€317/hour technical review, ~€325/hour QMS audit, €1,540 application fee, €1,160 fixed certificate cost. Premium fast-track NBs charge €650–€1,100/hour.
Class III cost (€200,000–€600,000+) is dominated by clinical evidence. A clinical investigation, where required, costs €100,000–€500,000 alone. Add full QMS assessment with design dossier examination for every device, the Clinical Evaluation Consultation Procedure (expert panel), testing (€20k–80k), and consulting (€30k–100k). The NB assessment for Class III ranges €50,000–€250,000.
Annual compliance ranges from ~€29,000 to €160,000+ by class: NB surveillance audits (€5k–25k), certificate maintenance (€500–10,600), EU AR retainer (€3k–15k), post-market surveillance and PSUR, EUDAMED maintenance, ISO 13485 surveillance, and for Class III, product liability insurance (€3k–7k).
Class I devices that are non-sterile, non-measuring, and not reusable surgical instruments are self-certified — no Notified Body fees. Their cost (€8,000–€26,000) covers QMS, technical documentation, EU Authorised Representative, and EUDAMED. Class I sterile, measuring, or reusable surgical devices pay reduced NB fees for the specific aspect only.
Get itemised Notified Body quotes — compare costs under IR 2026/977
From February 2027, NBs must provide standardised, itemised quotations. Submit your device on ECP to receive structured cost and timeline estimates from Notified Bodies with capacity for your class — and compare them side by side.
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