MDR · IVDR · application · audit · technical review · surveillance
How much does Notified Body certification cost under the MDR and IVDR?
The certificate is one line on the budget. The assessment hours behind it write the real invoice.
There is no universal price list for CE certification. A useful budget separates entry fees, audit time, technical and clinical review, decision charges and the recurring cost of keeping the certificate alive.
Build the cost picture ↓Initial assessment
+Lifecycle costs
One defined scope
The short answer
Expect a scoped quotation, not an EU price tag
Notified Bodies must publish their standard fees under MDR Article 50 and IVDR Article 46. Those public schedules reveal the charging logic, but they cannot tell a manufacturer the final price before the body understands the product and assessment scope.
Published 2026 rates show why first certification can move quickly into tens of thousands of euros. One application fee may be modest, while several audit and technical-review days create most of the total. A complex portfolio, special consultation or repeated review can take the project into six figures.
Do not ask only what the certificate costs. Ask how many assessed days, files, sites and review cycles the quotation assumes.
No common tariff
Each designated body sets and publishes its own standard charging structure.
No quote without scope
Class, route, portfolio, sites and evidence determine the work to be priced.
No finish at certification
Surveillance, maintenance, changes and recertification continue the cost.
Before estimating anything
First find out which assessment you are buying
The wrong risk class or conformity route makes every later number meaningless.
Manufacturer self-declaration
Conventional MDR class I devices and non-sterile IVDR class A devices normally do not require Notified Body involvement.
- The manufacturer still completes technical documentation
- The QMS and post-market obligations still apply
- Classification must be documented and defensible
Usually not applicable
Limited Notified Body involvement
For MDR class Is, Im and Ir devices and sterile class A IVDs, the Notified Body assessment is restricted to the regulated special aspect.
- Sterility controls for class Is and sterile class A
- Metrological requirements for class Im
- Safe reuse aspects for class Ir
Focused but recurring
Notified Body conformity assessment
MDR classes IIa, IIb and III and IVDR classes B, C and D require Notified Body involvement through the applicable route.
- Quality-management-system assessment and surveillance
- Technical-documentation review or sampling
- Additional procedures for certain higher-risk devices
Scope-dependent
Confirm classification, qualification and conformity route before requesting quotations. A polished cost comparison built on the wrong regulatory pathway is still wrong.
Interactive planning model
Turn published day rates into a first-cycle scenario
This editable model uses selected fees from BSI’s public MDR schedule effective 1 January 2026. It demonstrates how the invoice grows. It does not estimate another Notified Body’s price and does not replace a formal quotation.
€51,496
Selected published fees · excluding VAT and exclusions belowTravel and expenses
Unannounced audits
External consultation
Laboratory testing
Repeat review and remediation
Consulting and internal effort
The default scenario combines the published €3,024 application fee, four audit days, one technical file reviewed for eight days, one clinical-evaluation review day, the lowest listed annual maintenance fee and a €504 certificate decision fee. Real scoping and invoicing may use different units, minima and activities.
Fee anatomy
The invoice follows the assessment journey
Every line should connect to a task, rate, assumption and trigger for extra work.
- 01Entry
Application and administration
Application review, onboarding, scope changes and contract administration can carry flat or hourly charges.
- 02System
Quality-management-system audit
Audit time reflects headcount, sites, shifts, processes, outsourced activity, device complexity and the selected route.
- 03Product
Technical-documentation assessment
The number of files and review depth depend on class, portfolio structure, sampling and device-specific risk.
- 04Evidence
Clinical or performance review
Evaluation reports, investigations, performance studies, equivalence and post-market evidence may need specialist assessment.
- 05Decision
Certification and maintenance
Decision, certificate issuance and annual maintenance may appear separately from assessment hours.
- 06Outside input
Travel, testing and consultation
Expenses, external laboratories, medicinal-substance consultation and specialist panels can sit outside normal day rates.
What moves the number
Complexity is expensive. Unresolved complexity is worse.
The manufacturer cannot remove every cost driver, but it can stop ambiguity from multiplying them.
Devices, families and Basic UDI-DIs
More technologies, categories and generic device groups can expand technical-documentation sampling.
Novelty and risk
Implants, software, combination products and unfamiliar technologies may require deeper specialist review.
Clinical or performance maturity
Weak search methods, unsupported equivalence or unresolved benefit-risk questions create extra review rounds.
Sites, headcount and outsourcing
Multiple locations, critical suppliers, shifts and complex outsourced processes affect audit planning.
Consultations and product-specific procedures
Medicinal substances, human or animal tissues, companion diagnostics and certain high-risk devices add external steps.
Submission quality and response control
An internally inconsistent dossier turns assessment time into investigation and remediation time.
The avoidable premium
Poor readiness is billed twice
The manufacturer pays once for additional Notified Body time and again through delayed market access, diverted staff and compressed commercial decisions.
01Classification rationale disagrees with intended purpose
02Device-family structure changes after quotation
03Clinical claims outrun the available evidence
04Risk controls cannot be traced into verification
05Suppliers and sites are missing from the audit scope
06Responses are fragmented across several uncontrolled owners
After the first decision
Certification is a subscription to continued scrutiny
A first-cycle quotation is only the opening chapter of the conformity budget.
Application and initial assessment
Contract review, QMS audit, technical and evidence review, nonconformity closure and certification decision.
Largest concentrated spendSurveillance and maintenance
Scheduled surveillance, certificate administration and ongoing technical-documentation sampling.
Recurring baselineChanges and post-market review
Significant changes, PSUR review, new sites, portfolio changes and corrective-action follow-up.
Variable event costUnannounced audit and recertification
Unannounced assessment and the full renewal work needed before the certificate cycle ends.
Planned reserveAsk for a lifecycle forecast that includes the initial assessment, each surveillance year, expected technical-file sampling, change scenarios, unannounced audit assumptions and recertification. The cheapest first invoice can produce the highest five-year cost.
Comparing quotations
Make the scope identical before comparing the totals
A quotation is useful only when its assumptions are visible.
Check designation before price
A Notified Body must be designated for the applicable MDR or IVDR legislation and the codes covering the device. Verify the current NANDO entry, not only a sales presentation.
Open NANDO ↗Choose the assessment partner, not only the day rate
Relevant competence, reviewer availability, communication, language, predictability and change handling can matter more than a small rate difference.
A low headline price is not a saving if essential work was omitted from the scope.
Beyond the Notified Body invoice
Certification cost is not market-access cost
The Notified Body invoice pays for independent assessment. The manufacturer still funds the system and evidence being assessed.
Notified Body
Application · audit · review · certificate · surveillance
Readiness
QMS · technical files · clinical evidence · testing · remediation
Access
Authorised representative · registration · translation · insurance · maintenance
Practical questions
Notified Body cost FAQ
Open the question that affects your first quotation or lifecycle budget.
Is there a fixed EU price for Notified Body certification?+
No. The MDR and IVDR require Notified Bodies to publish lists of standard fees, but they do not impose one EU-wide tariff. The final quotation depends on the applicable legislation, designation scope, device portfolio, assessment route, audit duration, technical-documentation sampling, clinical or performance evidence and any special consultation procedure.
Does every medical device manufacturer need a Notified Body?+
No. A conventional MDR class I device may normally be self-declared. Notified Body involvement is limited for class Is, Im and Ir devices, and for sterile class A IVDs. MDR classes IIa, IIb and III and IVDR classes B, C and D require Notified Body involvement. Classification and the chosen conformity-assessment route must be confirmed for the specific product.
What is usually the largest part of the first certification invoice?+
For many manufacturers, technical-documentation assessment and quality-management-system audit time dominate the first cycle. Complex technology, several device groups, weak clinical or performance evidence, multiple sites and repeated review rounds can increase those hours substantially.
Is ISO 13485 certification included in an MDR or IVDR quotation?+
Not necessarily. An MDR or IVDR conformity assessment examines the regulatory quality-management system, while a separate ISO 13485 certificate is a distinct service unless the quotation expressly combines them. Ask the Notified Body to identify each certificate, audit activity and fee separately.
Are application fees refundable if certification does not proceed?+
This depends on the Notified Body contract. Application and administration work may remain payable even if the application is withdrawn, rejected or does not progress. Read the cancellation, postponement, minimum-charge and refund provisions before signing.
Does the Notified Body review every technical file?+
Not always. The applicable conformity-assessment route, risk class and portfolio structure determine whether every device or representative samples are assessed. The Notified Body develops the sampling plan using device categories, generic device groups, Basic UDI-DIs and the risks and technologies involved.
Which costs continue after the certificate is issued?+
Typical recurring costs include annual certificate maintenance, surveillance audits, technical-documentation sampling, reviews of post-market reports, change assessments, travel and periodic unannounced audits. Recertification creates another substantial cycle before certificate expiry.
How should manufacturers compare Notified Body quotations?+
First make the scope comparable. Give each candidate the same device list, classes, Basic UDI-DI structure, sites, headcount, outsourced processes and certification route. Then compare assumptions, included hours, sampling, travel, external experts, revision rounds, surveillance, change fees and recertification rather than comparing only the headline total.
Primary sources
Verify the legal route and the live tariff
Fee schedules and designations change. Use the current published documents when building or approving a certification budget.
European Commission Notified Bodies overview
Role, designation and public-fee requirement
Commission list of published fee schedules
Links for MDR and IVDR Notified Bodies
BSI MDR fee schedule 2026
Source for the illustrative calculator rates
Regulation (EU) 2017/745
Articles 50 and 52 and Annex IX
Regulation (EU) 2017/746
Articles 46 and 48 and conformity routes
NANDO designation database
Current bodies, legislation and scope codes
Price the right scope
Need a defensible certification budget before requesting quotations?
MDRC can clarify the classification and conformity route, structure the device portfolio, identify likely technical-documentation samples and build a readiness plan around the work the Notified Body will assess.
