What Makes a Best Economic Operator?
Introducing the BEO Model
Why “Good Enough” EOs Aren’t Good Enough Anymore
If you ask most manufacturers how they choose their Economic Operators, you’ll hear answers like “they’re reputable,” “we’ve always used them,” or “they came recommended.” Rarely will you hear, “we evaluated them against MDR Article 11, 13, or 14 obligations and tested their vigilance workflows.” But that’s exactly what MDR/IVDR expects manufacturers to do.
The Best Economic Operator (BEO) Model exists because too many manufacturers choose partners blindly — and too many operators believe they’re compliant when they’re not.
The BEO Model turns the vague idea of “compliance quality” into something structured, objective, and measurable.
The Problem with How Manufacturers Evaluate EOs Today
Manufacturers historically used soft criteria when choosing operators. They looked at:
Price
Geographic location
Brand reputation
Speed of communication
Existing business relationships
None of these things have anything to do with meeting MDR/IVDR expectations. And yet manufacturers trust operators based on these superficial markers every day.
The BEO Model was designed to fix that.
What Actually Makes an EO “Best”?
A Best Economic Operator isn’t the cheapest, the friendliest, or the fastest. A BEO is the operator who consistently performs the legal tasks they’re responsible for — and does so with evidence.
A BEO is defined by:
Competence
Documentation
Process maturity
Understanding of MDR/IVDR
Ability to act quickly in regulatory situations
This isn’t subjective. It’s observable.
Why the BEO Model Uses Binary Scoring
The heart of the BEO Model is simplicity: either an operator is compliant, or they’re not.
There’s no “mostly compliant” under MDR.
If an importer doesn’t verify CE marking, they are noncompliant.
If a distributor doesn’t record complaints properly, they are noncompliant.
If an AR doesn’t maintain documentation, they are noncompliant.
Binary scoring removes arguments and excuses. It also removes ambiguity — the thing regulators hate most.
Why the Weighted Requirements Matter
Not every requirement carries the same regulatory weight. Some failures create minor nuisances, while others can escalate into market withdrawals or safety notices.
Critical areas such as the PRRC, vigilance capability, EUDAMED registration, and AR mandate verification carry far heavier consequences when they collapse. Weighted scoring ensures that the areas with the greatest regulatory impact receive the greatest evaluation focus.
The Emotional Side Manufacturers Don’t Admit
Manufacturers often feel “locked in” with EOs. Maybe they’ve known them for years. Maybe the EO helped them during a crisis. Maybe the relationship feels too personal to question.
But MDR/IVDR compliance isn’t personal — it’s regulatory. And regulators won’t care how good your relationship is when something goes wrong.
The BEO Model gives manufacturers permission to ask the hard questions.
How to Recognize a True BEO Immediately
A strong EO shows its quality not through claims, but through behavior.
A BEO:
Provides documents before you ask
Knows MDR/IVDR well enough to explain it
Has a PRRC who is active, not symbolic
Maintains a working vigilance system
Can produce EUDAMED evidence on the spot
These are the hallmarks of a genuinely compliant operator.
Why the BEO Model Protects More Than Compliance
This model protects reputation, financial stability, audit readiness, and long term market access. Manufacturers who use it stop choosing operators based on convenience and start choosing them based on verified competence.
In the MDR/IVDR era, that difference is enormous.
