Understanding Economic Operators Under MDR/IVDR
Why Economic Operators Became the Backbone of EU Compliance
When the MDR and IVDR landed, many manufacturers assumed the hardest part would be technical documentation or clinical evidence. But as the regulations rolled out and Competent Authorities began enforcing them, something unexpected happened: the spotlight shifted to the people in the supply chain. Economic Operators — a term that hardly mattered under the old directives — suddenly became central to everything.
The EU realized a long time ago that weak points in the supply chain created weak points in patient safety. Devices were entering Europe without proper verification. Some incidents weren’t reported. Some distributors operated in complete regulatory darkness. MDR and IVDR were designed to fix that, and the solution was simple: make everyone accountable.
That’s why understanding Economic Operators isn’t just an academic exercise. It’s the difference between stable market access and ongoing regulatory risk.
The Manufacturer: Still Responsible, but No Longer Alone
Manufacturers are still the primary owners of compliance, but the regulations changed how they must work with others. Today, a manufacturer isn’t just responsible for the device itself — they’re responsible for ensuring that every operator they work with is performing the duties assigned to them.
This is where many frustrations begin. A manufacturer can have immaculate documentation, a flawless QMS, and a compliant DoC, but if their importer never actually checks it, the manufacturer is still the one who gets questioned by authorities.
Manufacturers quickly learned that MDR/IVDR isn’t just about producing good documentation — it’s about building a trustworthy, verifiable compliance network.
The Authorised Representative: No Longer a Mailbox
Under the old directives, many ARs acted like document couriers. MDR/IVDR completely flipped that dynamic. Article 11 transformed the AR into a legal partner with actual skin in the game. They’re now jointly liable for defective devices, which shocked many ARs who weren’t prepared for the level of scrutiny that came with it.
Modern AR expectations include:
Verifying technical documentation exists and is complete
Managing the DoC and device registration
Acting as the primary contact for regulators
Maintaining copies of essential documents
Managing vigilance communications
If your AR hasn’t modernized since MDR went live, you’ve already outgrown them.
The Importer: The New Regulatory Gatekeeper
Importers historically focused on logistics — moving boxes, managing shipping, handling customs. Under MDR/IVDR, importers became something entirely different: the first regulatory checkpoint in the EU.
Importers must verify CE marking, confirm AR appointment, check labelling and UDI, maintain traceability, and keep documentation accessible. Competent Authorities routinely inspect importers now, and when they find gaps — and they do — the manufacturer is the one who receives the call.
The biggest problem? Many importers still believe verification is optional.
The Distributor: The Last Line of Defense
Distributors may not have the same responsibilities as ARs or importers, but they hold an equally important position: maintaining conformity once the device is already in Europe. They’re responsible for storage, transport conditions, complaint handling, and basic verification steps.
Most distributors don’t think of themselves as regulatory actors, and that’s where manufacturers get burned. The number of vigilance failures that trace back to distributors is larger than most imagine.
Why Misunderstanding EOs Leads to Real Problems
Talk to any manufacturer who’s faced a Competent Authority inspection and they’ll tell you: EO failures are often the root cause of findings. The most common issues include:
Importers not verifying DoCs
ARs not maintaining technical documentation
Distributors not forwarding complaints
EUDAMED registration gaps
Missing vigilance communication paths
The irony is that most EO-related findings are preventable — but only if manufacturers understand and actively manage the roles.
How Manufacturers Lose Control Without Realizing It
The biggest trap is assuming operators know what they’re doing. Many say they comply. Far fewer can prove it. The MDR/IVDR ecosystem doesn’t reward assumptions. It rewards evidence.
A manufacturer who doesn’t monitor their EOs is like a pilot who trusts the fuel gauges but never checks them. Eventually, something goes wrong.
The Bottom Line
Understanding Economic Operators isn’t optional — it’s foundational.
MDR/IVDR created a shared responsibility environment, but manufacturers still sit at the center. When one operator fails, the risk rolls uphill. The best manufacturers are the ones who invest time not only in their own compliance, but in ensuring the entire chain is strong, reliable, and verifiable.
