How long does CE marking take?

In short: Industry sources, including regulatory consultancies and market analysts, commonly cite 12–18 months for Class IIa–III software, measured from starting the QMS and technical file to certificate. Notified Body review and backlog are the least controllable part; documentation gaps found in review are the most common self-inflicted delay. Class I self-certification is substantially faster.

What the 12–18 months actually covers

That window runs from the point you seriously begin building your quality management system and technical file to the point you hold a certificate — it's not just Notified Body review time. In practice it breaks into two phases: internal preparation (QMS build, clinical evaluation, technical documentation), which is largely within your control and can be compressed with focused effort and the right expertise, and Notified Body review, which is not — application-slot backlogs and review-cycle length are set by the Notified Body's own capacity, not your responsiveness.

The two things that move this number most

Notified Body backlog is the least controllable variable: securing an application slot can itself take months before substantive review even starts, which is why approaching candidates early, well before your file is finished, matters more than most founders initially assume. A Notified Body's designation scope must also cover your device type — for niche software that narrows which bodies you can even apply to. Documentation gaps are the most controllable one, and also the most common self-inflicted delay — a technical file with a weak GSPR checklist, a thin clinical evaluation report, or missing verification evidence generates review-cycle questions that add months, often more time than the gap would have taken to close properly the first time.

What moves faster

Class I self-certification skips Notified Body review entirely and can move at the pace of your own documentation work — a matter of a few months for a team that already has a reasonably mature QMS, rather than over a year. This is one reason getting your classification confirmed early matters as much for timeline as it does for cost: the class you land in sets which of these two very different timelines you're on. Looking ahead: the Commission's December 2025 MDR/IVDR simplification proposal (COM(2025) 1023) would introduce fixed Notified Body decision timelines and a risk-based Rule 11 that could move some software to the faster Class I track — a proposal, not law (realistically ~2027 at the earliest), so plan against the current picture.

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