Medical Device CE Certification Cost (EU MDR 2017/745) – 2026
Medical device manufacturers planning to enter the European market must understand that CE Marking costs under EU MDR 2017/745 can vary significantly. Device classification, technology complexity, clinical evidence availability, and the level of Notified Body involvement all play a major role in determining the final cost.
In 2026, MDR compliance costs continue to rise and understanding what drives those costs is the first step to budgeting your CE Marking project accurately.
CE Certification Cost by Medical Device Risk Class
CE Marking cost under EU MDR 2017/745 is not a fixed figure. It depends on several technical, regulatory, and clinical factors. The risk class of the device is the single biggest cost driver, but the overall project cost is also shaped by technology complexity, availability of clinical evidence, legacy device status (mdd), applicable testing and validation requirements, software and cybersecurity involvement, the scope of Notified Body review, and the number of models or product variants within the certification scope. The estimates below reflect 2026 consulting fees by device class.
Class I Medical Devices CE Certification Cost
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, and latest MDCG guidance | ✓ | ✓ |
| 2 | Identify applicable mechanical, electrical safety, EMC, wireless, environmental, functional safety and biocompatibility test requirements (if applicable) | ✓ | ✓ |
| 3 | Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 4 | Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities | ✓ | ✓ |
| 5 | Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards | ✓ | ✓ |
| 6 | Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents by incoperating PMSR | ✓ | ✓ |
| 7 | Prepare, review, and compile complete Technical Documentation ensuring compliance with MDR 2017/745 and GSPR | ✓ | ✓ |
| 8 | Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 💴 |
Total Fee
|
$5,000 | $6,000 |
Class Is / Im / Ir - EU MDR CE Certification Cost
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Conduct GAP Assessment against available documents in line with EN ISO 13485 and MDR 2017/745 | ✓ | ✓ |
| 2 | Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 3 | Identify applicable mechanical, electrical safety, EMC, wireless, environmental, biocompatibility and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable) | ✓ | ✓ |
| 4 | Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 5 | Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities | ✓ | ✓ |
| 6 | Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards | ✓ | ✓ |
| 7 | Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents by incorporating PMSR and PMCF | ✓ | ✓ |
| 8 | Prepare, review, and compile complete Technical Documentation ensuring GSPR and MDR 2017/745 Notified Body expectations | ✓ | ✓ |
| 9 | Notified Body application preparation, coordination with NB review team, support for non-conformity responses and technical queries, revision control and safeguarding of technical documentation until CE certification is granted | — | ✓ |
| 10 | Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 11 | Prepare ISO 13485 quality manual, mandatory procedures, and key templates (implementation not in scope) | — | ✓ |
| 💴 |
Total Fee
|
$8,500 | $13,500 |
Class IIa - Medical Device CE Certification Fees
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Conduct GAP Assessment against available documents in line with ISO 13485 and MDR 2017/745 | ✓ | ✓ |
| 2 | Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 3 | Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per the latest ISO 10993-1 series | ✓ | ✓ |
| 4 | Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable) | ✓ | ✓ |
| 5 | Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 6 | Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities | ✓ | ✓ |
| 7 | Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards | ✓ | ✓ |
| 8 | Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents | ✓ | ✓ |
| 9 | Conduct and Report PMS, PMCF, and PSUR per MDR and latest MDCG guidance | ✓ | ✓ |
| 10 | Prepare, review, and compile complete Technical Documentation ensuring compliance with GSPR, Harmonized Standards and MDR 2017/745 and Notified Body expectations | ✓ | ✓ |
| 11 | Notified Body application preparation, coordination with NB review team, support for non-conformity responses and technical queries, revision control and safeguarding of technical documentation until CE certification is granted | — | ✓ |
| 12 | Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 13 | Prepare ISO 13485 quality manual, mandatory procedures, and key templates (implementation not in scope) | — | ✓ |
| 💴 |
Total Fee
|
$9,000 | $14,000 |
Class IIb CE Certification Cost
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Conduct GAP Assessment against available documents in line with ISO 13485 and MDR 2017/745 | ✓ | ✓ |
| 2 | Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 3 | Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per the latest ISO 10993-1 series | ✓ | ✓ |
| 4 | Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable) | ✓ | ✓ |
| 5 | Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 6 | Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities | ✓ | ✓ |
| 7 | Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards | ✓ | ✓ |
| 8 | Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents | ✓ | ✓ |
| 9 | Conduct and Report PMS, PMCF, and PSUR per MDR and latest MDCG guidance | ✓ | ✓ |
| 10 | Prepare comprehensive GSPR checklist covering all applicable sections with detailed justifications, objective evidence, test references, and applicable harmonized standards | ✓ | ✓ |
| 11 | Prepare, review, and compile complete Technical Documentation ensuring compliance with MDR 2017/745 and Notified Body expectations | ✓ | ✓ |
| 12 | Notified Body application preparation, coordination with NB review team, support for non-conformity responses and technical queries, revision control and safeguarding of technical documentation until CE certification is granted | — | ✓ |
| 13 | Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 14 | Prepare ISO 13485 quality manual, mandatory procedures, and key templates (implementation not in scope) | — | ✓ |
| 💴 |
Total Fee
|
$11,000 | $17,000 |
Class III Medical Device CE Certification Fees
| # | Service Scope | Premium | Assured |
|---|---|---|---|
| 1 | Conduct GAP Assessment against available documents in line with ISO 13485 and MDR 2017/745 | ✓ | ✓ |
| 2 | Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents | ✓ | ✓ |
| 3 | Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per the latest ISO 10993-1 series | ✓ | ✓ |
| 4 | Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable) | ✓ | ✓ |
| 5 | Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation | ✓ | ✓ |
| 6 | Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities | ✓ | ✓ |
| 7 | Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards | ✓ | ✓ |
| 8 | Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents | ✓ | ✓ |
| 9 | Conduct and Report PMS, PMCF, and PSUR per MDR and latest MDCG guidance | ✓ | ✓ |
| 10 | Prepare comprehensive GSPR checklist covering all applicable sections with detailed justifications, objective evidence, test references, and applicable harmonized standards | ✓ | ✓ |
| 11 | Prepare, review, and compile complete Technical Documentation ensuring compliance with MDR 2017/745 and Notified Body expectations | ✓ | ✓ |
| 12 | Notified Body application preparation, coordination with NB review team, support for non-conformity responses and technical queries, revision control and safeguarding of technical documentation until CE certification is granted | — | ✓ |
| 13 | Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope | — | ✓ |
| 14 | Prepare ISO 13485 quality manual, mandatory procedures, and key templates (implementation not in scope) | — | ✓ |
| 💴 |
Total Fee
|
$15,000 | $23,000 |
CE Certification Pricing — Terms & Conditions
GERMANY – INDIA – MALAYSIA – PORTUGAL – UNITED KINGDOM – UNITED STATES
MDR Technical Documentation & Notified Body Coordination Fee
CE Certification Pricing - General Information
Notified Body Fees Under EU MDR — 2026
The following fees are charged directly by the Notified Body and are billed separately from I3CGlobal fees.
| # | Description of Activity | Charges (€ Euros) |
|---|---|---|
| 1 | MDR 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 MDR Pricing
What is included in MDR Technical Documentation?
MDR 2017/745 Technical Documentation includes device description, GSPR checklist, Risk Management, Clinical Evaluation, PMS, PMCF, labeling, and other Annex II & Annex III requirements.
More details about technical file table of contents
Is ISO 13485 mandatory for CE marking?
Yes, EN ISO 13485:2016 Implementation is mandatory and NOT ISO 13485 Certification.
What is the cost of a Clinical Evaluation Report under MDR?
We provide Clinical Evaluation writing service. Check our MDR CER writing service Fee.
What is the difference in cost between MDR and IVDR certification?
The main fee difference between MDR and IVDR is the fee charged by Notified Bodies and the cost involved in clinical evaluation in MDR and Performance evaluation in IVDR
Why is MDR certification expensive?
If you have ever looked at an MDR certification quote and done a double take, you are not alone. The costs can feel overwhelming — and there is a real reason for that. MDR raised the bar significantly compared to the old MDD. The documentation alone is a major undertaking: Clinical Evaluation Reports, Post-Market Clinical Follow-up plans, risk management files, full Technical Documentation — none of this can be put together overnight, and none of it can be done without experienced regulatory people behind it. On top of that, a lot of devices that sailed through under MDD now sit in higher risk classes under MDR, which means Notified Body involvement that manufacturers never had to budget for before.
Then come the Notified Body fees, which catch many manufacturers off guard. You are looking at €250 to €600 per hour for Technical Documentation review, and the average device needs around 32 hours of that review alone. Add onsite audit costs, the fixed certification charge, and the possibility of an unannounced audit, and the bill grows fast. There are also far fewer MDR-designated Notified Bodies than there used to be, which means longer wait times and less room to negotiate — the demand is simply outpacing the capacity.
What many people do not fully appreciate upfront is that MDR certification does not end at approval. Post-Market Surveillance is ongoing, safety reports need to be filed regularly, and your QMS needs to stay audit-ready year after year. And if your product line includes multiple models, variants, accessories, or software — each one adds to the documentation workload and the overall cost. It is a significant commitment, but understanding what drives the expense makes it a lot easier to plan for it properly.
Information in this page about MDR Consulting Fees / CE Marking Consultancy Cost with items wise MDR cost breakdown developed and created by Sara Moly on 16th May 2026. Approved by Soio George