pragma · compliance · regulatory radar
Auto-refresh 12h · last 09:42 CET 06.06.2026
Compliance · v01 · the regulatory radar
The same engine, focused on what could stop us.
Vigilant's scraper crawls regulators, news, search trends, social, and competitor activity once a day. Vigilant routes the findings to growth. Compliance routes the same findings through a regulatory lens — IGJ inspection register, MDR classification, AVG/GDPR Article 9 biometric, the claims register, the ethical-AI declarations. Same data. Different verb. If Vigilant is the demand engine, Compliance is the brake we audit once a week so Pragma never has to slow down.
System live · 9 regulators watched · 12 claims registered · 0 open advisories
01 · Today's compliance signals · auto-refreshed
What the regulators did since yesterday.
0 · open
No new Dutch Healthcare Inspectorate item affecting cryo · redlight · HBOT this week.
→ Review Mon 09:00
1 · advisory
Wellness device marketing guidance updated — clarifies physiotherapy disclaimer language.
→ Audit BE copy by Fri
5 / 5 · class I
All 5 cabins still Class I medical-adjacent · non-invasive · self-declaration · no notified body needed.
→ No action
10 / 12 · cleared
"Boost immune system" + "anti-ageing" flagged — both promotional, neither clinical.
→ Rewrite 2 lines
100% · consent
All biometric capture (photo · sleep score) under explicit Article 9 consent gate.
→ Audit signed copy
Ethical-AI register
All declared
3 / 3 · live agents
Voice agent · WhatsApp coach · recommender — all declare AI explicitly, no voice cloning.
→ Quarterly attest
All · 3 sites
CMP shipped · granular consent · NL+EN · no pre-checked optional cookies.
→ Quarterly scan
3 · months left
Liability cover renewal 30.09.2026 · raise cap to €5M before Antwerp opens.
→ Broker brief 30d
02 · Regulator watchlist · 3 jurisdictions
Who we watch and what we listen for.
Pragma operates in NL primary, BE expansion, LU plan. Three regulators, two ministries, one EU framework. Vigilant crawls each daily; Compliance reads the findings through the lens of "could this stop us from running a session, shipping an install, or making a marketing claim?"
Netherlands · primary
IGJ + RIVM
Healthcare Inspectorate · NL
- MDR medical-device advisoriesD-0
- Wellness vs medical positioningD-7
- Cryo session duration guidanceD-14
- HBOT pressure / venue rulesD-30
- Photobiomodulation claimsD-30
Belgium · expansion
FAGG + SPF Santé
Federal Agency for Medicines · BE
- Wellness device marketing guidanceD-0
- FR / NL labelling parityD-14
- Antwerp municipal licensingD-30
- VAT on wellness sessionsQ3
EU horizontal
EU MDR + AVG
Reg. 2017/745 + 2016/679 · EU
- MDR Class I self-declarationlive
- AVG Art. 9 biometric consentlive
- AI Act limited-risk disclosureD-90
- DSA cookie + ad disclosurelive
- Cross-border data residencyQ4
03 · Medical Device Regulation · cabin classification
Where each cabin sits in EU MDR.
Five Pragma° cabins, all Class I medical-adjacent under MDR Annex VIII Rule 9 (active devices intended for therapy with no notified body). Self-declaration valid. No CE mark concerns. The shield is the disciplined claim register below — therapy language must stay wellness-grade.
| Cabin | MDR class | Annex VIII rule | Notified body | CE | Renewal | Self-declaration |
|---|
e°CABIN
Whole-body cryo | Class I | Rule 9 · active | Not required | Self-cert | 2027-03 | Filed 2024 |
X°CRYO
Localised cryo | Class I | Rule 9 · active | Not required | Self-cert | 2027-03 | Filed 2024 |
LedPro
Red light + NIR | Class I | Rule 9 · light therapy | Not required | Self-cert | 2027-03 | Filed 2024 |
OxyPro
Hyperbaric chamber | Class IIa watch | Rule 9 · pressure dev. | Optional review Q3 | Audit | 2026-09 | Re-file Q2 |
X-TONE
HIEMT muscle stim | Class I | Rule 9 · stimulation | Not required | Self-cert | 2027-03 | Filed 2024 |
★ OxyPro on watch — pressure-device subclass may shift to Class IIa pending FAGG review. Mitigation: limit operating pressure to 1.5 ATA (already capped), maintain operator-supervised session rule.
04 · The claims register · 12 marketing claims audited
Every line that touches a member or operator passes through here.
Pragma's risk is not the equipment — it is the language. A "wellness journey" claim runs flat through MDR. A "treats inflammation" claim does not. Vigilant flags every new marketing line against this register before it ships. Compliance owns the register; Brand owns the rewrites.
✓
"Forty minutes in the Arctic room. Three degrees lower than yesterday."
Sensory experience — no therapeutic claim. Wellness-safe.
Hero · Health
Approved
v01 · 06.04
✓
"Supports post-exercise recovery and cellular repair."
Verb "supports" + non-clinical outcome. AVG/MDR safe.
LedPro · catalog
Approved
v02 · 28.05
!
"Boost your immune system in 90 minutes."
"Boost" + immune is a therapeutic positioning — IGJ guidance treats this as a medical claim.
OxyPro · brochure
Rewrite
flagged 04.06
!
"Anti-ageing therapy that resets your skin."
"Anti-ageing" + "therapy" = double trigger. Strip both.
LedPro · social
Rewrite
flagged 03.06
✓
"Designed for wellness, not medicine. Sessions are supervised."
Explicit disclaimer — required on every B2C surface. Approved master line.
Footer · all sites
Approved
v01 · 02.06
✓
"Be unrecoverable."
Identity claim. Aspirational. No clinical promise. Safe.
Master · ATL
Approved
v01 · 06.06
✓
"Measured by Aalto. Trusted across two countries."
Factual credentialing — university partner cited with permission.
Group · press
Approved
v01 · 06.06
×
"Cures chronic fatigue."
Hard MDR trigger. Never publishes.
Influencer draft
Blocked
blocked 28.05
✓
"Stimulates motor neurons via electromagnetic energy for muscle toning."
Technical, mechanism-based, no outcome promise. Safe.
X-TONE · catalog
Approved
v01 · 28.05
✓
"AI may suggest a protocol based on your week. A coach always confirms."
Required AI Act disclosure + human-in-the-loop affirmation.
Booking flow
Approved
v01 · 04.06
✓
"This is a recorded voice assistant. It is not a person."
Voice agent opening line · AI Act compliant · no voice cloning.
Voice agent · NL/EN
Approved
v01 · 06.06
·
"50,000 sessions. One published standard."
Pending — number must verify against actual session log before Q1 2027 publication.
Group · Standard
Draft
parked Q4
05 · Ethical-AI register · the 3 live agents
Every AI surface declares itself. None of them clone a voice.
EU AI Act limited-risk classification for voice + recommendation. Each agent ships with an opening declaration, a human-handover route, and a quarterly attestation. No biometric ID. No voice cloning. No undisclosed scoring of members.
| Agent | Risk class | Declaration line | Human handover | Last attest | Status |
|---|
Voice agent · inbound
B2B demo booking · NL/EN |
Limited |
"This is a recorded voice assistant. It is not a person." |
Say "human" any time → Joël callback < 4h |
06.06.2026 |
Live |
WhatsApp coach
B2C 22:00 nudge · NL |
Limited |
"Berichten van pragma° zijn automatisch. Antwoord 'mens' voor een coach." |
Reply "mens" → live coach next business day |
04.06.2026 |
Live |
Protocol recommender
Booking flow · B2C |
Limited |
"AI may suggest a protocol based on your week. A coach always confirms." |
Studio coach signs off every Saturday batch |
02.06.2026 |
Live |
06 · This week's compliance queue · owner-named
Five moves before Friday.
| Priority | Move | Owner | Trigger | Due |
|---|
| High | Rewrite "Boost your immune system" + "Anti-ageing therapy"
Replace with sensory + outcome-supportive language. Resubmit to claim register. | Brand | Vigilant flag 04.06 | D+2 |
| Med | FAGG BE wellness-marketing guidance audit
Read new bulletin, audit BE copy parity, flag any drift. | Compliance | FAGG advisory 06.06 | D+4 |
| Med | OxyPro MDR re-file prep
Class I → Class IIa risk under review. Pull pressure logs + supervision rule docs. | Ops + Legal | Renewal 2026-09 | D+30 |
| Med | Insurance broker brief — raise cap to €5M for Antwerp
Current cap €2M. Antwerp opens Q1 — pre-event raise required. | CFO | Antwerp LOI signed | D+30 |
| Low | Quarterly AI agent attestation
3 agents · attest declaration line, handover route, no-clone discipline. | Compliance | Cadence Q2 | D+45 |
07 · How this surface reuses Vigilant
One scraper. Two lenses. Zero duplication.
The reuse contract
Compliance is not a separate tool — it is a route on the Vigilant signal bus.
Every signal Vigilant scrapes (regulator bulletin, news item, search trend, social mention) hits the same enrichment + scoring pipeline. The Compliance lens applies a regulatory taxonomy on top: it asks "could this slow us down?" while the Vigilant lens asks "could this grow us?" When Pragma signs and lifts the workshop, they get one engine — not two. One scraper to maintain, one dataset to back up, one taxonomy to evolve. The cost of compliance becomes marginal.