🪪 The Real Licence

Getting a medical device certified in Europe now takes 18 to 24 months, for want of enough notified bodies to issue the stamp. So a medtech that already holds certification owns something a faster rival cannot buy, at any price, for two years. The certificate is now worth as much as the product, and funds are buying companies for the stamp alone.

On 29 June, the same Union did the reverse. The Council waved through the Digital Omnibus, pushing the AI Act’s high-risk obligations back by 16 months: hiring, credit scoring, education. Due on 2 August 2026, they will now arrive in December 2027. Same machinery, opposite reflex. On medical devices, Brussels lets scarcity harden into a barrier. On AI, it reaches for pause the moment the deadline starts to bite.

Which is where the fashionable claim collapses, the one that casts regulation as Europe’s great competitive edge. The rule is not what protects you. Rules move. The Omnibus has just shown that a date turns negotiable at the precise point it begins to hurt. To stake a company on a deadline holding is to bet on the constancy of Brussels, which has just folded under Draghi-era pressure. What does not move is the ability to clear a hard bar while it is still hard, and the few who manage it.

Banking already ran the experiment. In five years the middle of the table emptied out. The neobanks left standing are the handful that secured a real licence, bunq among them. The graveyard is full of those that treated the licence as a luxury to afford later. For the survivors it worked as a filter. It removed everyone else.

The moat and the logjam are one object seen from two sides. Whoever holds the stamp has every reason to keep it rare, and so to keep the door shut behind them. The mechanism that rewards the first movers bolts it for the next. For a continent forever promising to build more challengers, that is an awkward admission: the barrier shielding its winners is the same barrier throttling its next cohort. No one in Brussels genuinely adjudicates that trade, and the incumbents are in no rush to force it.

The lesson is neither to worship the constraint nor to curse it. It is to stop mistaking the moat for the rule that digs it. Rules change, as the Omnibus has shown once more. The scarcity they have already produced does not renegotiate. It is the one asset Brussels cannot claw back in trilogue: the ground taken while the bar stood high.