From when exactly does this apply?
The regulation entered into force on 10 December 2024. The reporting obligation for actively exploited vulnerabilities and severe incidents applies from 11 September 2026; most of the remaining obligations, including the essential requirements and CE marking, apply from 11 December 2027. So the reporting obligation is the first one that will affect you, and it depends on work that cannot be done in a few weeks: you can only report within 24 hours if you know within 24 hours that something affects you.
Does our software fall under this?
Probably, yes. It covers products with digital elements placed on the European market, which is a broad category: standard software, firmware, connected devices, and also standalone software components that are placed on the market independently. There are exceptions, including for products already covered by specific sector legislation and for open source that is not offered commercially. Bespoke work you build for a single client is more nuanced; we assess that case by case.
We only sell within the Netherlands. Does it still apply?
Yes. The regulation applies to products made available on the market of the European Union, and the Netherlands is part of that. There is no threshold based on turnover or company size. There is some relief for small and micro enterprises on parts of the documentation obligations, and the Commission is working on simplified formats. That does not change the reporting obligation itself.
What exactly does the five-year support period involve?
During the support period you must fix vulnerabilities and make security updates available. That period is at least five years, unless the expected lifetime of the product is shorter; if it is longer, support follows the lifetime. Importantly, this concerns security updates and not new functionality. In practice, it mainly affects your versioning policy: you must still be able to build and deliver an older release.
How does this relate to the Cybersecurity Act?
They target different things. The Cyber Security Act, the Dutch implementation of NIS2, focuses on your organisation and your services; the CRA focuses on the product you place on the market. If you are affected by both, the underlying processes overlap, such as risk management, incident handling and supply chain security, but the evidence you need to provide differs. We set up those processes so that you maintain them once and can use them in two places.
Do we have to make an SBOM public?
No. The obligation is that you have one and can provide it to the market surveillance authority on request, in a commonly used machine-readable format and covering at least the top-level dependencies. What you share with customers is your own decision. In practice we see that customers do ask for it, and including it is an advantage in procurement processes, as it shows that the overview exists.
What happens if we don't report?
Enforcement runs through the national market surveillance authority, and the maximum fines in the regulation are substantial: for breaches of the essential requirements, up to fifteen million euros or two and a half per cent of worldwide annual turnover, whichever is higher. In practice, most conversations weigh more heavily on the fact that a product can be withdrawn from the market and that customers ask about it during their procurement process.
We use a lot of open source. What does that mean?
It means you include those components in your overview, and that the vulnerabilities in them become your responsibility once you place the product on the market. The maker of the open-source component does not bear that obligation, unless it is offered commercially. There is a separate, lighter role for open-source stewards, such as foundations behind major projects. For you as a manufacturer, little changes: you are responsible for what you supply.
Do we need an external body for this?
It depends on the category your product falls into. For most products, a self-assessment with technical documentation and an EU declaration of conformity is sufficient. For important and critical categories, such as password managers, firewalls or operating systems, stricter routes apply, sometimes involving a notified body. We determine that category during scoping, as it shapes the rest of the process.
What is realistic if we start today?
The component inventory and signal sources are the quickest to put in place and deliver the most value, because the reporting deadline depends on them. The reporting process itself is mostly about agreeing responsibilities and rehearsing it once. Delivering updates over the long term is the longest-running part, especially if devices are already in the field. We lock that sequence into the gap analysis, so that what becomes mandatory first is also finished first.
Do you also carry out the conformity assessment yourselves?
No. We are not a notified body and we do not issue CE marking. What we deliver is the work underneath: the engineering, process and documentation you need to go into the assessment, whether it is a self-assessment or handled through a third party. In projects where a notified body is involved, we work alongside the partner you choose and provide whatever they request.