MDR costs for manufacturers (including for a small company)
The MDR costs for a manufacturer consist of three parts: the notified body, your own staff, and external evidence such as testing and clinical evaluation. For a class I product without a notified body, the cost mostly comes down to internal hours. From class IIa onwards, you quickly pay tens of thousands of euros to the notified body in the first year, plus an annual fee to maintain the certificate.
There are no fixed government rates. However, under Article 50 of the EU MDR 2017/745 , every notified body must publish a list of standard rates, in the format of MDCG 2023-2 . The biggest cost driver is the MDR risk class of your product. For what the ISO 13485 certificate itself costs, read ISO 13485 costs and timeline.
All amounts on this page are indications. The notified body rates come from a public rate list; the number of hours varies per product and per organisation. Always request a quote based on your own file.
What do MDR costs consist of?
MDR costs are broader than the notified body’s invoice. This table shows which items you need to budget for and what they depend on.
| Cost item | What it is | What it depends on |
|---|---|---|
| Notified body | Application, audits of your quality system, assessment of technical documentation, certificate, annual fee | Class, number of products, number of sites, quality of your file |
| Technical documentation | Building and maintaining the product file | Complexity of the product, what you already have |
| Clinical evaluation | Literature review, clinical data, sometimes a clinical investigation | Class and novelty of the product |
| Testing | Biocompatibility, electrical safety, software validation, sterilisation | Materials, energy source, sterility |
| Quality system | Setting up and maintaining, often according to ISO 13485 | Existing system and company size |
| Regulatory capacity | The mandatory person responsible for compliance (PRRC) and day-to-day work | Internal or hired externally |
| Post-market surveillance | Post-market surveillance, periodic safety reports, vigilance | Class and number of products sold |
What does a notified body charge under the MDR?
Notified bodies charge by the hour or by the day, plus fixed amounts for the application and the certificate. As an example, here is the public rate list of TÜV Rheinland LGA Products (NB 0197) , valid from 27 October 2025 for services provided from Germany.
| Item | Rate | Range in the list |
|---|---|---|
| Application | €2,480 fixed | €2,480 |
| Issuing certificate | €3,450 fixed | €3,450 to €15,000 |
| Annual certificate fee | €2,410 fixed | €2,410 to €15,000 |
| Quality system audit | €310 per hour | €2,480 to €55,800 per audit |
| Unannounced audit | €310 per hour, minimum 2 auditors for 1 day | €4,960 to €20,460 |
| Technical documentation assessment | €410 per hour | €9,840 to €78,720 |
| Clinical evaluation assessment | €430 per hour | €3,440 to €52,000 |
| Travel time | €160 per hour | Excluding hotel and travel costs |
Other notified bodies use a similar structure, but with different amounts. So compare not only the hourly rate, but above all the number of hours they estimate for your product. For how to choose a body, read choosing a notified body.
An incomplete file is the most expensive mistake. Every extra assessment round of your technical documentation is billed by the hour. A file that is right the first time saves thousands of euros.
Worked example: MDR costs for a small company with one class IIa product
A medtech company with 8 employees brings one class IIa product to the market: a device without an implant or a medicinal product. The quality system is already in place. We only calculate the notified body costs, using the rates from the table above. The hours are assumptions for this example.
| Year 1 item | Calculation | Amount |
|---|---|---|
| Application | Fixed | €2,480 |
| Quality system audit | 4 auditor days × 8 hours × €310 | €9,920 |
| Technical documentation assessment | 40 hours × €410 | €16,400 |
| Issuing certificate | Fixed | €3,450 |
| Travel time | 6 hours × €160 | €960 |
| Total notified body year 1 | €33,210 |
In the years after, you pay less, but the costs do not stop. Expect an annual audit, the annual certificate fee, and occasionally an unannounced audit.
| Each following year | Calculation | Amount |
|---|---|---|
| Annual audit | 2 auditor days × 8 hours × €310 | €4,960 |
| Annual certificate fee | Fixed | €2,410 |
| Unannounced audit | Minimum €4,960, at least once every 5 years | On average about €1,000 per year |
| Total per year (indication) | about €8,400 |
Internal costs come on top of this. For a small company, these are often the biggest item: building the technical documentation and the clinical evaluation takes months of work. For how to phase this smartly as a startup, see ISO 13485 for medtech startups.
MDR costs per risk class
The class determines how deeply the notified body reviews your product, and therefore how many hours you pay for. This table shows the relative differences, not amounts.
Class I
No notified body, unless your product is sterile, has a measuring function or is a reusable surgical instrument. Your costs sit in the technical documentation, the clinical evaluation, your quality system and the registration in EUDAMED. For a small company, this is the cheapest route.
Which MDR costs can a small company reduce?
A small company cannot avoid the MDR, but it can plan smartly. Four choices make the biggest difference.
- Define the intended use tightly. A narrower intended use can place your product one class lower. See determining MDR risk classes.
- Outsource the PRRC. Micro and small enterprises do not need to employ the person responsible for regulatory compliance. That person must, however, be permanently and continuously available (Article 15(2) MDR).
- Bundle products in one application. For class IIa and IIb, a joint assessment per category or group can be cheaper than separate procedures.
- Use one system for MDR and ISO 13485. Have the same notified body combine your MDR audit and your ISO 13485 audit. This saves audit days.
Common mistakes when budgeting MDR costs
| Mistake | Consequence | Better approach |
|---|---|---|
| Budgeting only the notified body’s quote | Internal hours and testing fall outside the budget | Budget all seven items from the first table |
| No budget for re-assessment rounds | Each round costs hours at the documentation rate | Have the file reviewed internally first |
| Forgetting the annual costs | Cash flow problem after year 1 | Include the audit, the fee and unannounced audits |
| Underestimating waiting times | Reaching the market later, so revenue comes later | Ask for the expected timeline when requesting a quote |
| Starting the clinical evaluation too late | Delay at the document assessment | Start it at the same time as the design |
Further reading
- ISO 13485 costs and timeline: what the quality system and the certificate cost
- Choosing a notified body: comparing quotes and waiting times
- UDI and EUDAMED registration: the registration that applies to every class
- Technical documentation: what must be in the product file