CE Mark

The CE Mark (Conformité Européenne) is the regulatory approval marking required for medical devices and in vitro diagnostics (IVDs) to be legally placed on the market in the European Economic Area (EEA). Since May 2021, medical devices are regulated under the EU Medical Devices Regulation (MDR 2017/745), which replaced the previous Medical Device Directive (MDD). IVDs are regulated under the In Vitro Diagnostic Regulation (IVDR 2017/746).

Within the GAITS Funding Readiness Framework, CE Mark status is a Must-Have or Should-Have criterion depending on the funding level. For HealthTech and SaMD (Software as a Medical Device) companies, regulatory submission in progress or submitted is a Must-Have at Seed+ stage; regulatory advanced or completed is a Must-Have at Series A stage. Funders at these stages treat CE Mark progress as a primary risk indicator — a company without a clear regulatory pathway or with a stalled MDR process is carrying a significant unresolved risk.

The MDR imposes significantly more rigorous requirements than its predecessor (MDD), including stricter clinical evidence requirements, mandatory use of Notified Bodies for most device classes, and enhanced post-market surveillance obligations. Teams should note that CE Mark timelines under MDR are substantially longer than under MDD — often 18–36 months for Class II devices — and should factor this into their funding runway planning.