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CE Certification Cost for Medical Devices (EU MDR 2017/745) – 2026

CE certification cost under EU MDR 2017/745 depends mainly on the device risk class, the technology, the clinical evidence available and how much the notified body has to review. This page sets out I3CGLOBAL’s consulting fees by device class and the notified body charges to expect.

Notified body fees are charged separately by the notified body for audits, technical documentation review and certificates. Our CE marking consultants help you plan the full budget before you start.

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IMPORTANT TOPICS

Medical device manufacturers planning to enter the European market must understand that CE Certification cost 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 certification 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.

CE certification cost for medical devices: consulting fee, notified body fees, testing, clinical data and EU Rep costs

Your total CE certification cost under the MDR combines these five parts. The tables below show I3CGLOBAL’s consulting fees by device class.

Class I Medical Devices CE Certification Cost

#Service ScopePremiumAssured
1Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, and latest MDCG guidance✓✓
2Identify applicable mechanical, electrical safety, EMC, wireless, environmental, functional safety and biocompatibility test requirements (if applicable)✓✓
3Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation✓✓
4Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities✓✓
5Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards✓✓
6Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents by incoperating PMSR✓✓
7Prepare, review, and compile complete Technical Documentation ensuring compliance with MDR 2017/745 and GSPR✓✓
8Annual 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 ScopePremiumAssured
1Conduct GAP Assessment against available documents in line with EN ISO 13485 and MDR 2017/745✓✓
2Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents✓✓
3Identify applicable mechanical, electrical safety, EMC, wireless, environmental, biocompatibility and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable)✓✓
4Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation✓✓
5Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities✓✓
6Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards✓✓
7Prepare 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✓✓
8Prepare, review, and compile complete Technical Documentation ensuring GSPR and MDR 2017/745 Notified Body expectations✓✓
9Notified 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—✓
10Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope—✓
11Prepare 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 ScopePremiumAssured
1Conduct GAP Assessment against available documents in line with ISO 13485 and MDR 2017/745✓✓
2Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents✓✓
3Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per the latest ISO 10993-1 series✓✓
4Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable)✓✓
5Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation✓✓
6Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities✓✓
7Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards✓✓
8Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents✓✓
9Conduct and Report PMS, PMCF, and PSUR per MDR and latest MDCG guidance✓✓
10Prepare, review, and compile complete Technical Documentation ensuring compliance with GSPR, Harmonized Standards and MDR 2017/745 and Notified Body expectations✓✓
11Notified 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—✓
12Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope—✓
13Prepare 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 ScopePremiumAssured
1Conduct GAP Assessment against available documents in line with ISO 13485 and MDR 2017/745✓✓
2Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents✓✓
3Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per the latest ISO 10993-1 series✓✓
4Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable)✓✓
5Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation✓✓
6Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities✓✓
7Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards✓✓
8Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents✓✓
9Conduct and Report PMS, PMCF, and PSUR per MDR and latest MDCG guidance✓✓
10Prepare comprehensive GSPR checklist covering all applicable sections with detailed justifications, objective evidence, test references, and applicable harmonized standards✓✓
11Prepare, review, and compile complete Technical Documentation ensuring compliance with MDR 2017/745 and Notified Body expectations✓✓
12Notified 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—✓
13Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope—✓
14Prepare 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 ScopePremiumAssured
1Conduct GAP Assessment against available documents in line with ISO 13485 and MDR 2017/745✓✓
2Regulatory guidance via email on critical MDR 2017/745 compliance requirements — Articles, Annexes, Common Specifications, and latest MDCG guidance documents✓✓
3Prepare Biological Evaluation Plan (BEP) and identify applicable biocompatibility testing requirements per the latest ISO 10993-1 series✓✓
4Identify applicable mechanical, electrical safety, EMC, wireless, environmental, and functional safety testing requirements with corresponding IEC, ISO, EN, and ETSI standards where applicable)✓✓
5Perform and document Risk Analysis per ISO 14971 and compile the Risk Management File, integrate IEC 62366-1 usability engineering and prepare associated documentation✓✓
6Identify applicable product-specific, performance, software, cybersecurity standards, and associated activities✓✓
7Review, guide and support modification in Labels, IFU / User Manuals, per MDR and harmonized standards✓✓
8Prepare Clinical Evaluation Report (CER) per MDR Article 61, Annex XIV, MEDDEV 2.7/1 Rev.4, and applicable MDCG guidance documents✓✓
9Conduct and Report PMS, PMCF, and PSUR per MDR and latest MDCG guidance✓✓
10Prepare comprehensive GSPR checklist covering all applicable sections with detailed justifications, objective evidence, test references, and applicable harmonized standards✓✓
11Prepare, review, and compile complete Technical Documentation ensuring compliance with MDR 2017/745 and Notified Body expectations✓✓
12Notified 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—✓
13Annual European Authorized Representative Service and EUDAMED (Actor + SRN) activation — UDI Module not covered in scope—✓
14Prepare 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
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MDR Technical Documentation & Notified Body Coordination Fee

The above fee will increase based on the number of models, variants, accessories, critical components, software, drugs, cosmetic medical device, nanoparticles, systems, or kits.
Bulk discounts may apply for three or more MDR Technical Documentation projects Initiated simultaneously. Save up to 10%–20%
Clients who coordinate promptly with consultants and submit Files to NB within 3 to 5 months will qualify for additional discounts of respectively 20%, 10%, or 5%
Seperate fees apply for Drug Master File preparation for Medicinal Device / Combination Products.
ⓘ

CE Certification Pricing - General Information

Usually, MDR services do not require onsite visits. However, if the client requests our consultants will travel from Bangalore, Chicago, Charlotte, Düsseldorf, or London, travel and accommodation charges will be billed separately.
QMS/GMP Support not included. EN ISO 13485:2016 or Integrate with QMSR and IEC 62304 is available but on additional project request
Additional Items to Budjet Notified Body + Lab Testing + Validations + Shelf life / Lifetime + ISO 13485 / IEC 62304 Implementation etc..
CE Marking timelines vary by device class and depend on three key factors (1) Quality of Technical Documentation (2) Notified Body's current review capacity, and (3) Manufacturer's QMS implementation readiness
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Notified Body Charges to Budget For — 2026

The following fees are charged directly by the Notified Body and are billed separately from I3CGlobal fees, so add them to your total CE certification cost. For the full list of fees by notified body, see our notified body fee guide.

#Description of ActivityCharges (€ 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

ⓘ Source of information: Notified Body websites

View Notified Body Fee Page →
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Plan Your CE Certification Budget With I3CGLOBAL

Send us your device description and risk class. We will confirm the scope, our consulting fee and the notified body costs to expect, so you can budget your full CE certification cost from the start.

  • Clear consulting fees by device risk class
  • Technical documentation, clinical evaluation and notified body coordination
  • Bulk discounts of 10% to 20% for three or more projects
  • Consultants in Germany, India, Malaysia, Portugal, the UK and the USA

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FAQs

CE Certification Cost: Frequently Asked Questions

How much does CE certification cost under EU MDR?

At I3CGLOBAL, the consulting part of the CE certification cost, covering MDR technical documentation and notified body coordination, ranges from USD 5,000 for Class I devices to USD 23,000 for Class III devices, depending on the class and the service package. Notified body fees, testing and clinical investigations are paid separately.

What do notified bodies charge for MDR certification?

Notified body fees vary between notified bodies. Typical published rates are €250 to €600 per hour for technical documentation review, €250 to €300 per hour for QMS audits plus travel, a fixed certificate fee of around €1,500 and €5,000 to €7,000 for an unannounced audit. See our notified body fee guide.

Why is MDR certification expensive?

The MDR raised the bar compared with the old MDD. Manufacturers now need stronger clinical evidence, PMCF plans, detailed risk management, full technical documentation, UDI and EUDAMED registration, and closer notified body review. Each of these adds time from regulatory, clinical and quality specialists.

What is included in MDR technical documentation?

MDR technical documentation includes the device description, GSPR checklist, risk management, clinical evaluation, post-market surveillance and PMCF, labelling and the other requirements of Annexes II and III. See our technical file table of contents.

Is ISO 13485 certification mandatory for CE marking?

The MDR requires a quality management system under Article 10(9), and most manufacturers implement EN ISO 13485:2016 to meet it. Implementing the standard is expected, but a separate ISO 13485 certificate is not a legal requirement for CE marking.

What does a clinical evaluation report cost under the MDR?

The cost of a clinical evaluation report depends on the device, the available clinical data and the need for literature searches or equivalence. See our MDR CER writing fees for current prices.

What is the difference in cost between MDR and IVDR certification?

The main differences are the notified body fees and the clinical evidence work. MDR projects need a clinical evaluation, while IVDR projects need a performance evaluation covering scientific validity, analytical performance and clinical performance.

How can I reduce my CE certification cost?

Prepare complete information early and answer questions quickly. I3CGLOBAL offers bulk discounts of 10% to 20% when three or more MDR technical documentation projects start at the same time, and further discounts for clients who submit files to the notified body within 3 to 5 months.

How long does CE certification take under the MDR?

In the European Commission’s 20th notified bodies survey, with data to 28 February 2026, the most commonly reported time from signed agreement to certificate was 13 to 18 months. Preparing the technical documentation before the application adds several months, depending on the evidence available.

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CE Certification Cost Guides and Related Services

Updated | Author: Sara Moly, I3CGLOBAL | Reviewed by: Soio George, I3CGLOBAL