Most manufacturers pick Economic Operators based on reputation, price, or convenience - but “good enough” isn’t enough under MDR/IVDR. The Best Economic Operator Model shows how to evaluate operators objectively, ensuring compliance, competence, and peace of mind.

Before MDR/IVDR, manufacturers often assumed their operators were compliant - but appearances can be misleading. The BEO Scoring System gives a clear, evidence-based way to measure operator performance and manage risk.

Assuming your Economic Operators are compliant is a risk you can’t afford under MDR/IVDR. EO audits give manufacturers clear insight, uncover hidden gaps, and turn assumptions into verified compliance.

Choosing the right Economic Operator isn’t just a business decision—it’s a regulatory strategy. The right EO protects your compliance, strengthens vigilance, and prevents costly surprises under MDR/IVDR.

Economic Operators are no longer just partners—they’re the backbone of MDR/IVDR compliance. Understanding their roles and responsibilities is essential for manufacturers to maintain control, prevent regulatory gaps, and protect market access.

Not all EO obligations carry the same weight under MDR/IVDR. Critical Requirements—like PRRC appointment, vigilance, and EUDAMED registration—are non-negotiable foundations that determine whether an operator can truly support compliance.

Selecting the right importer isn’t just logistics—it’s a regulatory safeguard. Using an evidence-based evaluation framework like the BEO model ensures importers meet MDR/IVDR obligations, maintain vigilance, and protect long-term compliance.

Choosing the right Authorised Representative isn’t a back-office task—it’s a strategic compliance decision. Using a structured, weighted evaluation like the BEO framework ensures ARs meet MDR/IVDR obligations, maintain vigilance, and protect long-term regulatory and market access.