Healthcare & MedTech · regulation · Analysis
Europe's medical device rules did what they were designed to do. They also priced out the small manufacturer.
MDR raised the evidentiary floor for medical devices and software. The unintended effect has been a steady migration of early European health technology companies toward a US-first launch.
Independent coverage
By Andy Oram
Contributing Writer — Health AI / Open Source · Freelance
Edited by Dr. Elin Lindqvist, MD · Medically reviewed by Dr. Anders Bjørnsson, MD
Published 18 August 2026
8 min read
Evidence: Analysis
The European Medical Device Regulation was a response to real failures. Implants that should never have reached patients, clinical evidence that did not exist, notified bodies that competed on leniency. On those terms it worked.
The cost has landed unevenly. A large manufacturer absorbs MDR as a regulatory affairs function. A twelve-person company with a class IIa software device absorbs it as most of its runway.
Where the cost actually sits
Three line items dominate in the cases reviewed for this piece. Clinical evaluation, which for software often means generating evidence that did not previously exist for the intended purpose. Notified body capacity, where waiting time is now a planning assumption rather than an administrative detail. And post-market clinical follow-up, a permanent obligation rather than a launch cost.
The third is the one founders systematically underestimate. It is also the one that most directly improves patient safety, which is why arguments for removing it are weaker than arguments for resourcing it.
The migration pattern
The behaviour this produces is consistent. A European health software company incorporates in Europe, builds its clinical relationships in Europe, and then launches first in the United States because the regulatory pathway for a comparable device is faster and the reimbursement conversation is more legible.
European clinical evidence generated by European hospitals ends up supporting a US launch, with the European launch following two years later.
What would change it
Notified body capacity is the binding constraint and the most tractable. It is a workforce problem with a known solution: more assessors, trained and paid.
The second, harder change is a proportionate route for low risk software devices with a genuine clinical purpose, distinct from the wellness category on one side and from implantable hardware on the other.
Neither change requires weakening the evidence standard. Both require treating regulatory throughput as infrastructure.
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