Regulatory & Reimbursement
Claim, evidence and market access have to move together.
The pathway is designed around a conservative first claim covering performance and safety. Classification, conformity-assessment route and clinical requirements remain subject to formal review with qualified counsel and a Notified Body.
Regulatory hypothesis
Preliminary MDR class IIb — to be confirmed.
The planning assumption for Europe is class IIb. What matters more than the class is the honest cost structure behind it: the dominant driver is our own people, not the fees.
TÜV Rheinland price list v3.0, 27 October 2025 (application fee € 2,480; annual certificate maintenance € 2,410–15,000) · MedTech Europe Survey 2024, n = 211 · Team-NB Survey 2025: 48 % of cases take 13–18 months, and 58 % of elapsed time is manufacturer response time.
Claim ladder
Each claim earns its own evidence.
A performance-and-safety claim requires materially less evidence than a neurological outcome claim. Choosing the narrow claim first is what makes the programme financeable.
Define it narrowly
Population, setting, operators, duration and therapeutic purpose drive classification and the evidence requirement. This is decided first, not last.
Performance and safety
A temperature-performance claim supported by airway-safety evidence is the lower-risk route to market and the one currently planned.
Neurological outcome
Any survival or neurological-benefit claim requires a separate, substantially larger programme. It is not part of the current financing case.
Under the MDR, 63 % of manufacturers surveyed in the pneumology, anaesthesia and intensive care segment reported withdrawing products from the market (DIHK, MedicalMountains and SPECTARIS 2023, n = 393). We treat that as a planning parameter, not as background noise.
Reimbursement
There is no reimbursement mechanism. That is the finding.
Under § 133 SGB V, health insurers contract on remuneration wherever state or municipal law does not set charges. Vehicles and medical devices are financed through user charges — not from a separate investment budget. A price premium therefore has to be passed through the charge calculation of each individual district. There is no nationwide mechanism and no DRG-style payment for a prehospital device.
Regular procurement
Value has to be demonstrated to clinical, operational and purchasing stakeholders inside existing care budgets. This is what the financial model assumes.
Health economics
Workflow, time, resource use and patient outcomes require transparent data before any purchasing argument holds.
Policy pathway
A trial-related payment under § 137e SGB V, or any other special mechanism, is treated as upside only. The dual financing recommended by the Government Commission has not been implemented.
§ 133 SGB V · Bundestag Research Services WD 9-3000-093/23: responsible bodies are districts, independent cities and special-purpose associations; only Baden-Württemberg is organised under private law · Government Commission, 9th statement, 7 September 2023, drawing on the Federal Audit Office report 2018 · Our position paper on the emergency-care reform refers to BT-Drs. 21/6808.
Status notice
No approval and no reimbursement claim.
This page describes planning assumptions. It does not state that AIRCHILL holds regulatory approval, a final classification, reimbursement coverage or authorisation for routine clinical use.
Regulatory and health-economics expertise wanted.
We are looking for a Notified Body with a capacity commitment for class IIb, quotations for the standards package, and people who have taken a prehospital device through the MDR.