Economic Operator Support
Under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), the concept of the “economic operator” introduced a new layer of regulatory accountability across the medical device supply chain. Manufacturers, authorised representatives, importers, and distributors now carry specific, legally defined responsibilities that extend beyond commercial arrangements. These obligations include traceability, documentation retention, product verification, complaint handling, and cooperation with competent authorities. For organisations marketing devices in the European Union, failure to clearly define and operationalise these roles can result in non-compliance, market interruptions, or enforcement actions.
Our Economic Operator Support services assist clients in interpreting, implementing, and sustaining compliance with the obligations assigned to each actor under Articles 10, 11, and 13–14 of the MDR and IVDR. We begin by assessing the existing supply chain structure, contractual relationships, and procedural controls that govern product distribution and representation. This assessment identifies overlaps, gaps, and ambiguities in responsibilities that may expose the organisation to regulatory or commercial risk.
We then support the formal designation and documentation of each economic operator role. For non-European manufacturers, this includes the selection and qualification of an Authorised Representative (AR) with appropriate regulatory competence, resources, and liability coverage. We review and, where necessary, draft or update the mandate agreements that define obligations, communication channels, and documentation exchange protocols between the manufacturer and the AR. Our consultants ensure that agreements meet the legal requirements set out in MDR Article 11 and that liability arrangements are clearly defined.
For organisations operating as importers or distributors, we establish the procedural frameworks necessary to comply with Articles 13 and 14. This includes verification of CE marking, EU declaration of conformity, registration requirements, and traceability obligations. We assist in designing incoming goods inspection processes, complaint handling workflows, and product withdrawal procedures that align with both regulatory expectations and commercial logistics systems. Where multiple entities handle products, we develop oversight mechanisms to ensure consistency of compliance across jurisdictions and partners.
Documentation and data flow management are also critical. We help clients implement traceability systems that maintain visibility of devices from manufacturer to end user, supported by structured documentation archives. These systems enable efficient retrieval of technical and conformity records during inspections or market surveillance activities. In addition, we integrate economic operator compliance into the broader quality management system (QMS), ensuring that supplier control, vigilance reporting, and PMS activities are fully connected to operational procedures.
Our approach emphasises practicality and risk mitigation. By clarifying obligations, defining communication pathways, and establishing monitoring procedures, we reduce the likelihood of duplication or omission of key responsibilities. Clients benefit from enhanced regulatory confidence, improved supply chain control, and reduced exposure to liability in the event of product incidents or authority investigations.
The implementation of a robust economic operator framework also supports strategic scalability. For companies expanding into new EU markets or onboarding new distribution partners, the structure we establish provides a repeatable, audit-ready model that accelerates partner qualification and market entry.
Our consultants possess deep experience supporting multinational supply chains and collaborating with European Competent Authorities, enabling us to design compliance systems that satisfy both the letter and the intent of the law. We ensure that your organisation’s economic operator arrangements withstand regulatory scrutiny, facilitate seamless cooperation between stakeholders, and maintain product availability across all relevant markets.
For further information on how our Economic Operator Support services can help you establish compliant, transparent, and efficient supply chain governance under MDR and IVDR, please contact our regulatory compliance team.
