IVDR CE Certification Cost
(EU IVDR 2017/746) – 2026
IVDR certification is not cheap, and if you are just starting to look at costs, the numbers can be a shock. The old IVDD was one of the most lenient frameworks in the world. Most IVD devices never needed a Notified Body. That era is over. Under EU IVDR 2017/746, the rules are tighter, the evidence bar is higher, and for most device classes, a Notified Body is now part of the process whether you like it or not.
What you will pay depends heavily on what you are certifying. A Class A IVD device and a Class D blood screening test are worlds apart in terms of cost and effort. The risk class of your device is the biggest cost driver but it is not the only one. How much performance data you already have, how many product variants are in scope, whether software is involved, and frankly how organized your documentation is when you come to us all of these have a real impact on the final number.
We built this page because manufacturers kept asking us the same question “just tell me roughly what this will cost”. The pricing below covers Class A through Class D, based on real project experience. It is a starting point, not a fixed quote every device is different. But it should give you a realistic sense of what to expect before we talk.
IVDR CE Certification Cost by IVD Device Class
Under EU IVDR 2017/746, in vitro diagnostic medical devices are classified into four risk classes. Class A, Class B, Class C, and Class D based on their intended purpose, risk to the patient, and potential impact on public health. Unlike the old IVDD framework where approximately 80% of IVD devices were self-certifying, IVDR now requires Notified Body involvement for Class B, C, and D devices, significantly increasing the scope and cost of certification for the majority of IVD manufacturers.
The IVDR CE certification cost varies considerably depending on the device class, complexity of the analytical and clinical performance evidence required, number of analytes or variants, software involvement, and the level of Notified Body review. The pricing tables below provide transparent cost estimates for each device class from Class A self-certification to Class D high-complexity IVD devices to help manufacturers plan and budget their IVDR compliance journey in 2026.
Class A : IVD CE Marking Cost
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Regulatory Guidance Guidance via email on critical IVDR 2017/746 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 2 | Testing Requirements Identification If Applicable Identify applicable mechanical, electrical safety, EMC, wireless, environmental, functional safety, and biocompatibility testing requirements for IVD devices, including IEC 61010-1, IEC 61010-2-101, IEC 61326-1, IEC 61326-2-6, applicable ISO and EN standards, and ETSI wireless standards under EU IVDR 2017/746 | ✓ | ✓ |
| 3 | Risk Management File Perform and document Risk Analysis per ISO 14971, compile the Risk Management File, integrate IEC 62366-1 usability engineering, and prepare associated documentation | ✓ | ✓ |
| 4 | Software & Cybersecurity Standards If Applicable Identify applicable product-specific, performance, software, and cybersecurity standards and associated activities | ✓ | ✓ |
| 5 | Labels & IFU Review Review, guide, and support modification of Labels and IFU / User Manuals per IVDR 2017/746 and applicable harmonised standards | ✓ | ✓ |
| 6 | Performance Evaluation, PMS & PMPF Prepare Performance Evaluation Reports (PER), Post-Market Surveillance (PMS), and applicable Post-Market Performance Follow-up (PMPF) documentation in accordance with EU IVDR 2017/746 Article 56 and Annex XIII, covering scientific validity, analytical performance, clinical performance, and post-market performance evaluation activities per latest MDCG guidance documents | ✓ | ✓ |
| 7 | Technical Documentation & GSPR Compliance Prepare, review, and compile complete Technical Documentation ensuring full GSPR compliance with IVDR 2017/746 | ✓ | ✓ |
| 8 | EU Authorised Representative & EUDAMED Annual European Authorised Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 💴 | Total Fee | $5,000 | $6,000 |
Class A Sterile : IVD CE Marking Cost
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Regulatory Guidance Guidance via email on critical IVDR 2017/746 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 2 | Testing Requirements Identification If Applicable Identify applicable mechanical, environmental, functional safety, and biocompatibility testing requirements for IVD devices under EU IVDR 2017/746 | ✓ | ✓ |
| 3 | Risk Management File Perform and document Risk Analysis per ISO 14971, compile the Risk Management File, integrate IEC 62366-1 usability engineering, and prepare associated documentation | ✓ | ✓ |
| 4 | Sterilization Process Review sterilization validation records and cleanroom controls, packaging integrity and shelf-life related to sterility | ✓ | ✓ |
| 5 | Labels & IFU Review Review, guide, and support modification of Labels and IFU / User Manuals per IVDR 2017/746 and applicable harmonised standards | ✓ | ✓ |
| 6 | Performance Evaluation, PMS & PMPF Prepare Performance Evaluation Reports (PER), Post-Market Surveillance (PMS), and applicable Post-Market Performance Follow-up (PMPF) documentation in accordance with EU IVDR 2017/746 Article 56 and Annex XIII, covering scientific validity, analytical performance, clinical performance, and post-market performance evaluation activities per latest MDCG guidance documents | ✓ | ✓ |
| 7 | Technical Documentation & GSPR Compliance Prepare, review, and compile complete Technical Documentation ensuring full GSPR compliance with IVDR 2017/746 | ✓ | ✓ |
| 8 | EU Authorised Representative & EUDAMED Annual European Authorised Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 💴 | Total Fee | $9,000 | $14,000 |
Class B : IVD CE Certification Fees
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Regulatory Guidance Critical IVDR 2017/746 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 2 | Biological Safety & Biocompatibility Optional Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per ISO 10993-1 series | ✓ | ✓ |
| 3 | Risk Management File Perform and document Risk Analysis per ISO 14971, compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 4 | Testing Requirements Identification Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements for IVD devices, including IEC 61010-1, IEC 61010-2-101, IEC 61326-1, IEC 61326-2-6, applicable ISO and EN standards, and ETSI wireless standards under EU IVDR 2017/746 | ✓ | ✓ |
| 5 | Software & Cybersecurity Standards Optional Identify applicable product-specific, performance, software, and cybersecurity standards and associated activities | ✓ | ✓ |
| 6 | Labels & IFU Review Review, guide, and support modification of Labels and IFU / User Manuals per IVDR and harmonised standards | ✓ | ✓ |
| 7 | Performance Evaluation & Post-Market Performance Follow-up Prepare Performance Evaluation Report (PER) per IVDR Article 56, Annex XIII — covering scientific validity, analytical performance, and clinical performance — and conduct and report Post-Market Performance Follow-up (PMPF), PMS, and PSUR per IVDR and latest MDCG guidance | ✓ | ✓ |
| 8 | Technical Documentation & GSPR Compliance Prepare, review, and compile complete Technical Documentation ensuring full GSPR compliance with IVDR 2017/746 and Notified Body expectations | ✓ | ✓ |
| 9 | Notified Body Coordination & EU Authorised Representative Most Time Consuming Prepare and submit Notified Body application, coordinate with NB review team, manage non-conformity responses, revision control and safeguarding of Technical Documentation until CE certification is granted — including Annual European Authorised Representative Service and EUDAMED (Actor + SRN) activation. UDI Module not covered in scope. | — | ✓ |
| 10 | ISO 13485 QMS Documentation Prepare ISO 13485 quality manual, mandatory procedures, and key templates (implementation not in scope) | — | ✓ |
| 💴 | Total Fee | $9,000 | $15,000 |
Class C : IVD CE Certification Fees
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | GAP Assessment Against available documents in line with ISO 13485 and IVDR 2017/746 | ✓ | ✓ |
| 2 | Regulatory Guidance Critical IVDR 2017/746 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 3 | Biological Safety & Biocompatibility Optional Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per ISO 10993-1 series | ✓ | ✓ |
| 4 | Testing Requirements Identification Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards | ✓ | ✓ |
| 5 | Risk Management File Perform and document Risk Analysis per ISO 14971, compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 6 | Software & Cybersecurity Standards Optional Identify applicable product-specific, performance, software, and cybersecurity standards and associated activities | ✓ | ✓ |
| 7 | Labels & IFU Review Review, guide, and support modification of Labels and IFU / User Manuals per IVDR and harmonised standards | ✓ | ✓ |
| 8 | Performance Evaluation Report (PER) Prepare PER per IVDR Article 56, Annex XIII — covering scientific validity, analytical performance, and clinical performance per latest MDCG guidance | ✓ | ✓ |
| 9 | Post-Market Performance Follow-up (PMPF) Conduct and report PMS, PMPF, and PSUR per IVDR and latest MDCG guidance | ✓ | ✓ |
| 10 | GSPR Checklist Prepare comprehensive GSPR checklist covering all applicable sections with detailed justifications, objective evidence, test references, and applicable harmonised standards | ✓ | ✓ |
| 11 | Technical Documentation Prepare, review, and compile complete Technical Documentation ensuring compliance with IVDR 2017/746 and Notified Body expectations | ✓ | ✓ |
| 12 | Notified Body Coordination Most Time Consuming NB application preparation, coordination with NB review team, support for non-conformity responses, revision control, and safeguarding of Technical Documentation until CE certification is granted | — | ✓ |
| 13 | EU Authorised Representative & EUDAMED Annual European Authorised Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 14 | ISO 13485 QMS Documentation Prepare ISO 13485 quality manual, mandatory procedures, and key templates (implementation not in scope) | — | ✓ |
| 💴 | Total Fee | $13,000 | $19,000 |
Class D : IVD CE Marking Fees
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | GAP Assessment Against available documents in line with ISO 13485 and IVDR 2017/746 | ✓ | ✓ |
| 2 | Regulatory Guidance Critical IVDR 2017/746 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 3 | Biological Safety & Biocompatibility Optional Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per ISO 10993-1 series | ✓ | ✓ |
| 4 | Testing Requirements Identification Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards | ✓ | ✓ |
| 5 | Risk Management File Perform and document Risk Analysis per ISO 14971, compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 6 | Software & Cybersecurity Standards Optional Identify applicable product-specific, performance, software, and cybersecurity standards and associated activities | ✓ | ✓ |
| 7 | Labels & IFU Review Review, guide, and support modification of Labels and IFU / User Manuals per IVDR and harmonised standards | ✓ | ✓ |
| 8 | Performance Evaluation Report (PER) Prepare PER per IVDR Article 56, Annex XIII — covering scientific validity, analytical performance, and clinical performance per latest MDCG guidance | ✓ | ✓ |
| 9 | Post-Market Performance Follow-up (PMPF) Conduct and report PMS, PMPF, and PSUR per IVDR and latest MDCG guidance | ✓ | ✓ |
| 10 | GSPR Checklist Prepare comprehensive GSPR checklist covering all applicable sections with detailed justifications, objective evidence, test references, and applicable harmonised standards | ✓ | ✓ |
| 11 | Technical Documentation Prepare, review, and compile complete Technical Documentation ensuring compliance with IVDR 2017/746 and Notified Body expectations | ✓ | ✓ |
| 12 | Reference Laboratory Coordination Support coordination with EU Reference Laboratories (EURLs) required for Class D IVD devices under IVDR Annex IX | — | ✓ |
| 13 | Notified Body Coordination Most Time Consuming NB application preparation, coordination with NB review team, support for non-conformity responses, revision control, and safeguarding of Technical Documentation until CE certification is granted | — | ✓ |
| 14 | EU Authorised Representative & EUDAMED Annual European Authorised Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 15 | ISO 13485 QMS Documentation Prepare ISO 13485 quality manual, mandatory procedures, and key templates (implementation not in scope) | — | ✓ |
| 💴 | Total Fee | $17,000 | $25,000 |
IVDR CE Marking Fees — What You Need to Know
(Pricing notes, Bulk discounts, Travel charges)
IVDR Technical Documentation & Notified Body Coordination Fee
IVDR CE Certification Pricing - General Information
Notified Body Fees Under EU IVDR — 2026
The following fees are charged directly by the Notified Body and are billed separately from I3CGlobal fees.
| # | Description of Activity | Charges (€ Euros) |
|---|---|---|
| 1 | IVDR Technical Documentation Review Includes Clinical Evaluation. Dependent on risk class and file quality. (Avg. 32 hours required). | 250 — 600per hour |
| 2 | Medical Device QMS (EN ISO 13485) Onsite Audit Travel & lodging extra. Auditor travel time: €125 to €175 per hour. Client to organise stay / convenience. | 250 — 300per hour |
| 3 | Certification Charges Includes printing and dispatch. | 1,500fixed |
| 4 | Unannounced Audit Once during certification tenure or for vigilance issues. | 5,000 — 7,000 |
Frequently Asked Questions - EU IVDR Pricing
Do all IVD devices need a Notified Body under IVDR 2017/746?
What is the difference between MDR and IVDR certification cost?
MDR 2017/745 covers medical devices while IVDR 2017/746 covers in vitro diagnostic devices.
The certification costs differ in several important ways. IVDR requires a Performance Evaluation Report (PER) instead of a Clinical Evaluation Report (CER), which involves analytical performance studies, scientific validity assessments, and clinical performance data. For higher class IVD devices, particularly Class C and Class D, the performance evidence requirements can be more demanding than equivalent MDR devices, making IVDR certification potentially more expensive for complex diagnostics.
How long does IVDR certification take in 2026?
IVDR certification timelines in 2026 vary by device class and Notified Body capacity.
- Class A self-certification can typically be completed in 2-3 months with good documentation in place.
- Class B and Class C devices requiring Notified Body review typically take 12 to 18 months.
- Class D devices, those requiring reference laboratory consultation can take 18 to 24 months or longer depending on Notified Body workload and the quality of Technical Documentation submitted.
Why is IVDR certification more expensive than the old IVDD?
The old In Vitro Diagnostic Directive (IVDD 98/79/EC) was widely considered one of the least stringent regulatory frameworks in the world by approximately 80% of IVD devices were self-certifying under IVDD.
Under IVDR 2017/746, that has changed dramatically. Notified Body involvement is now required for a much larger proportion of devices, Performance Evaluation requirements are significantly more rigorous, Post-Market Performance Follow-up is mandatory, and QMS requirements are stricter. Due to this reason of substantially higher compliance burden, the cost IVDR is more compared to IVDD.
Information in this page about IVD Consulting Fees / IVDR Certification cost with items wise cost breakdown developed and created by Sara Moly on 17th May 2026. Approved by Soio George