“The longevity industry deserves a regulatory strategy as sophisticated as the science behind it.”
THE GENETICS COMPANY THAT WANTED A ENTRY BADGE, INSTEAD OF A SUBMISSION
A San Francisco-based company building genetic longevity tools reached out about EU market entry. The science was credible. The team was experienced.
Twenty minutes in, the actual ask became clear. They did not want a regulatory pathway. They wanted a CE mark as a market access signal. Something to show European partners that the product had cleared a credible bar.
Their framing: “This is a wellness product. It informs lifestyle choices. It does not diagnose.”
Then I asked what the platform tells a user when it flags elevated genetic risk for cardiovascular disease.
The answer: a risk score, a dietary protocol, a supplement recommendation, and a note to “discuss with your physician.”
That is not a wellness product. Under IVDR Article 2, if a product is intended to provide information about the physiological or pathological state of an individual, or about their predisposition to a medical condition, it is an IVD. Full stop. Intention is not determined by how the marketing copy is written. It is determined by what the product does and what a reasonable user does with the output.
The deeper problem was not regulatory. It was commercial. The CE mark was a credibility instrument for investor conversations. Regulatory compliance was being treated as a branding decision.
This pattern is more common than the industry acknowledges. And it matters because the products in question are making real claims about real health risks to real people.
THE GEOGRAPHY ARBITRAGE THAT BOTH SIDES ARE RUNNING
This one is structurally more interesting, and more representative of where the longevity diagnostics market actually sits right now.
A Series B European company selling a longevity diagnostic platform ran a doctor-owned model at home in the EU. Physician orders the test, interprets the result, takes clinical responsibility. Compliant. Defensible. The accountability chain is visible.
In the United States, the same company went direct-to-consumer. No prescribing physician. No clinical intermediary. Possible, because FDA enforcement on laboratory-developed tests has historically moved slowly.
Now flip the geography.
A US-based competitor, operating freely direct-to-consumer at home, wanted European access. No CE mark. No EU clinical validation. No Notified Body relationship. So they structured their EU entry as a clinic-owned model. The logic: if the clinic owns the diagnostic process, the clinic carries the clinical responsibility, and the product itself stays outside the regulatory perimeter.
Two companies. Two geographies. Each complying strictly where their regulator is watching, and exploiting the latitude where it is not.
The EU company exported its permissive behaviour to the US. The US company imported the EU’s clinic-ownership structure as a shortcut it had not earned. Both are technically within the rules today. Both are building on the assumption that enforcement stays slower than growth.
That is not a strategy. It is a countdown.
THE SPA THAT IS ALSO A DIAGNOSTICS CLINIC
There is a San Francisco-area concept that stopped me mid-sentence.
Private suites. Natural materials. Warm light. A central courtyard. The language throughout is of calm and restoration. Members are told they will leave feeling like they visited a wellness retreat, not a healthcare clinic.
The assessments inside: whole-body MRI, coronary CT angiography with AI vascular plaque characterisation, DEXA body composition, VO2 max, genetic risk profiling, multi-cancer early detection panels, metabolic blood panels, sleep apnea screening, neurodegenerative risk assessment. Thirty-plus evaluations in a single day.
The devices span three distinct regulatory frameworks in Europe.
The imaging hardware (MRI, CT, DEXA) falls under EU MDR as Class IIa or IIb devices, each requiring conformity assessment before lawful placement in service. The blood panels and genetic tests fall under IVDR, with performance requirements and, for higher-risk classifications, Notified Body involvement. The AI-assisted vascular analysis introduces a third layer, one the EU is actively resolving through the AI Act and MDR Article 22 on software as a medical device.
European hospitals run all of these modalities. The difference is that in a hospital, each device sits inside a governance structure that knows exactly which regulation applies, who is responsible for its clinical use, and what the accountability chain looks like when a result leads to a downstream decision.
The spa-clinic hybrid model creates ambiguity in that chain. When membership is the entry mechanism rather than clinical referral, when the brand promise is comfort rather than clinical rigour, when the experience is designed to feel unlike healthcare, the regulatory scaffolding becomes harder to see. And therefore harder to audit, defend, or scale across borders.
The diagnostics themselves are serious. Early-stage cancer findings, cardiovascular risk identification, neurodegenerative markers: these are not trivial outputs. They are exactly the kind of signals that justify the category.
The companies that have navigated this well (and some have) built the clinical infrastructure first and designed the experience around it. The result feels identical from the inside. The member in the private suite experiences the same calm. But underneath, every device is properly classified, every result has a named clinician, and every governance question has a documented answer.
You cannot decorate your way out of an IVDR submission.
WHAT THE FRAMEWORK ACTUALLY REQUIRES
The regulatory logic is not complicated, even when the products are.
IVDR Article 2 defines an IVD as any device intended to provide information about physiological or pathological state, predisposition to a medical condition, safety and compatibility with a potential recipient, or prediction of treatment response.
MDR applies the same logic to imaging devices, wearables, and software processing physiological data for clinical purposes.
The AI Act adds a third dimension: any AI system making risk predictions that inform health decisions sits in a high-risk category with specific transparency, validation, and human oversight requirements.
These are not obstacles. They are the mechanism by which the industry earns the right to make the claims it is making.
HOW TO BUILD THIS BETTER
Classify before you claim. Write your intended use statement in regulatory language before marketing language. What does the product tell the user? What will they do with that information? Is there a clinical decision in that chain? Answer those questions at the architecture stage, not the market entry stage.
Treat clinical validation as a moat, not a cost. The companies that have published peer-reviewed evidence for their diagnostic protocols are not just compliant. They are defensible. When enforcement comes (and it will), evidence is the only argument that holds.
Understand that the physician-in-the-loop model is not a workaround. In the EU, physician oversight is a genuine transfer of clinical responsibility requiring genuine clinical infrastructure. A note in the app saying “consult your doctor” is not a physician in the loop.
Stop treating the stricter market as the harder market. A product that demonstrates conformity with EU IVDR and MDR has cleared a bar that holds up across most of the world. That is not a burden. That is a competitive position.
Design the accountability chain before you design the experience. The most beautiful longevity clinic in the world is only as trustworthy as its regulatory infrastructure. Build that first. Then build the courtyard.
The longevity industry is attempting to shift medicine from reactive to proactive at scale. That mission deserves a regulatory strategy as sophisticated as the science behind it.
Not because the regulators demand it (though they do), but because the people walking into these clinics, giving their blood, their genetic material, and their trust, deserve a product held to the same standard as everything else in their clinical journey.
Build the evidence first. The experience will follow. It always should have.
