Is a 95,000€ IVDR certification quote typical for a small software manufacturer?

Anonymous · Published December 03, 2025 · 4 comments

Our company is pursuing IVDR certification for four software programs/algorithms that estimate disease risk based on genetic data. We did not require certification under IVDD but now must certify under IVDR. After applying to all notified bodies, we received an estimated price of 94,930€ for the certification service. There was no mention of follow-up audits, so they are likely not included. Our company has about 100 employees.

Is this a normal price for IVDR certification for such software products?

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Anonymous 6 months ago

Did the quote specify if the price covers all four products or just a subset? Was it for both audit and technical documentation assessment?

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Anonymous 6 months ago

Does the amount include surveillance audits or is it just for initial certification? Are your devices Class C?

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Anonymous 6 months ago

The scope should be detailed in the offer. Usually, there are separate amounts for the initial audit, technical documentation assessment per device, and yearly surveillance audits. Transparency on the breakdown should be provided.

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Anonymous 6 months ago

The cost can depend on company size.

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2 Answers

Accepted answer available

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory · 6 months ago

Based on our experience, that price does not sound far off for IVDR certification, especially for multiple software products. We have seen quotes in the range of 75,000€ and up, depending on the notified body and the scope of work. Some notified bodies offer a faster (designated technical documentation review) and a standard route, and prices can vary. It's important to check exactly what is included in the offer—initial certification, technical documentation assessment, and whether or not surveillance audits are covered.

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Anonymous · 6 months ago

I would recommend asking for a detailed, official offer. Without that, it's difficult to know exactly what is included in the price. If you need to file an application to get the offer, be aware that withdrawing the application will be documented with the notified bodies and authorities.

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