There is no price list for CE marking. What the European Commission and MedTech Europe surveys show about the duration and cost of an MDR certification, and how to read these averages for medical device software.
How long does it take, and what budget should you plan, to CE mark medical device software? The question comes up early, often while building a financing plan, and the answers in circulation vary widely. There is no price list: duration depends on the device class, the manufacturer's level of preparation and the Notified Body's (NB) workload, while cost depends above all on the work done in-house.
Public surveys nonetheless make it possible to set orders of magnitude. Here is what they show, and the precautions to take when applying them to software.
Four variables explain most of the differences observed from one project to the next:
The European Commission surveys of Notified Bodies indicate that most MDR certifications take between 13 and 18 months, and up to 19 to 24 months when the QMS and the product are assessed together. On the manufacturers' side, the MedTech Europe 2024 survey reports averages of 19.5 months for the QMS assessment and 21.8 months for the technical documentation assessment.
Two findings from the same survey shed light on how this time is spent. More than half of an assessment's duration falls outside the review itself, in the phases that precede it and in certificate issuance. And for half of the medical device manufacturers surveyed, at least one certificate was significantly delayed, or not granted, because the NB challenged the clinical evaluation.
These durations start when the file is submitted. They include neither setting up the QMS nor building the technical documentation, whose duration depends on each manufacturer's starting point. In class I, without an NB, the timeline rests entirely on this internal preparation.
The MedTech Europe survey provides a useful benchmark on the structure of spending. In the first year, 90% of the costs incurred to obtain and maintain certification correspond to the time teams spend on the QMS and the technical documentation, 7% to NB fees and 3% to regulatory maintenance per device.
For software, internal cost items include in particular:
Depending on the case, these are complemented by tooling (eQMS), external support and, for a manufacturer established outside the Union, the authorised representative required by Article 11 of the MDR. NB fees depend on the number of audit and review days, and therefore on the class and scope of the file. Fee schedules vary from one body to another and are worth comparing through quotes.
No survey provides a single price, but two published, dated reference points help frame the budget.
For a first certified software device, NB fees most often fall between 30,000 and 50,000 euros. For a startup certifying its first class IIa device, excluding "premium" bodies in the region of 100,000 euros or more. In class I, self-certification removes this cost item. External support, where used, represents an additional 50,000 to 150,000 euros depending on the provider and the billing model, according to the same source. The fee schedules that NBs publish under Article 50 of the MDR give these quotes their texture: technical documentation review runs from 200 to more than 900 euros per hour depending on the body, with most schedules between 225 and 430 euros.
The averages reported by manufacturers already certified are markedly higher. In the MedTech Europe 2024 survey, MDR-certified manufacturers report on average 136,981 euros in NB fees for the initial QMS certification and 176,202 euros for the technical documentation assessment, on top of internal personnel costs of around 1.6 million euros for the QMS and 3.4 million euros for the technical documentation. MedTech Europe itself notes that this last average, calculated on 26 respondents, is heavily driven by outliers. Nearly half of the panel are large, often multi-product companies, which explains the gap with the situation of a publisher certifying its first software device.
A certificate issued by an NB is valid for a maximum of five years (Article 56 of the MDR). During this period, the NB carries out a surveillance audit at least once a year and an unannounced audit at least once every five years (Annex IX). Post-market surveillance, documentation updates and software changes also generate continuous work.
According to MedTech Europe's simulations, maintenance and recertification costs exceed the cost of initial certification by around 50% over a five-year cycle for medical devices. These simulations use a reported average maintenance cost of 99,648 euros per device per year under the MDR. A budget built only on obtaining the certificate therefore underestimates actual spending.
These figures cover all medical devices, from software to implants, and a panel split almost equally between large companies and SMEs. MedTech Europe itself notes that some averages are driven by outliers. They do not allow the cost of a specific class IIa software to be deduced: the documentation scope, the class and any need for a clinical investigation vary the result considerably. They remain useful for what they show about the structure of costs and the stages where time is lost.
There is no standard cost or duration for CE marking. The available surveys place most Notified Body assessments between 13 and 24 months after submission, preparation not included, and show that most of the budget comes from internal work rather than NB fees. For a first class IIa software device, observed NB fees most often range from 30,000 to 50,000 euros. Over a five-year cycle, maintenance weighs more than obtaining the certificate. These benchmarks are mainly useful for building a realistic budget and timeline, to be adjusted afterwards to the actual scope of the device.
Sparta Care helps healthcare software and AI system publishers estimate and keep to their CE marking trajectory:
Contact us to establish an estimate tailored to your device. To measure the cost of a poorly scoped trajectory, see also our article on the measurable impact of regulatory wandering.
