MDR and the Obligations of Economic Operators: It's Not Just About the Manufacturer

Under the European Union's Medical Device Regulation (MDR - Regulation (EU) 2017/745), the burden of compliance no longer rests solely on the manufacturer. The MDR establishes a clear "chain of responsibility" that binds all Economic Operators within the supply chain. This means that from the Manufacturer, Authorised Representative (AR), Importer, to the Distributor, each party has specific, legally-binding obligations to fulfill.

Understanding these roles is critical for legally and safely placing a product on the EU market. This article will provide a detailed analysis of the key responsibilities for each party.

1. The Manufacturer: The Architect of Compliance

The manufacturer is the starting point and the foundation of the entire chain of responsibility. They not only create the product but must also build the entire body of evidence to prove its safety and effectiveness.

Key obligations include:

• Establish and maintain a Risk Management System: This is a continuous iterative process throughout the entire lifecycle of a device, requiring regular systematic updating.
• Conduct a Clinical Evaluation: Manufacturers must plan, conduct, and document a clinical evaluation in accordance with Article 61 and Annex XIV to confirm safety and performance requirements. This is an ongoing process of collecting, analyzing, and assessing clinical data related to the device.
• Draw up and maintain Technical Documentation: This documentation must allow for the assessment of the device's conformity with MDR requirements. The detailed contents are specified in Annexes II and III, covering everything from device description, design, and manufacturing information to the benefit-risk analysis.
• Implement a Quality Management System (QMS): All manufacturers must establish, document, implement, and maintain a QMS. This system must be proportionate to the risk class and type of device, ensuring effective compliance with the MDR. ITR is proud to be ISO 13485 certified for medical device design and development, a standard that reflects our commitment to quality.
• Implement Post-Market Surveillance (PMS): Manufacturers must proactively collect and review experience gained from their devices on the market. The PMS system is an integral part of the QMS and must be based on a detailed PMS plan.
• Draw up an EU Declaration of Conformity and affix the CE marking: After demonstrating conformity, the manufacturer must draw up an EU Declaration of Conformity and affix the CE marking to the product.

2. The Authorised Representative (AR): The EU Anchor for Global Innovators

For manufacturers not established in the EU, designating a sole Authorised Representative is mandatory to place a device on the Union market. The AR's role is far more than a simple contact address; they are the manufacturer's legal proxy in the EU.

Core obligations of the AR include:

• Verify documentation: Check that the EU Declaration of Conformity and technical documentation have been properly drawn up and that an appropriate conformity assessment procedure has been carried out by the manufacturer.
• Keep documentation available: Maintain a copy of the technical documentation, the EU Declaration of Conformity, and any relevant certificates to be provided to competent authorities upon request.
• Cooperate with authorities: Provide all necessary information and documentation to demonstrate a device's conformity and cooperate in any preventive or corrective actions.
• Legal Liability: The MDR explicitly states that the AR is legally liable for defective devices if a non-EU manufacturer has not complied with its general obligations. This highlights the critical importance of selecting a competent and trustworthy AR.

3. The Importer: The Gatekeeper to the Union Market

An importer is the entity that places a device from a third country on the EU market. They are the first "gatekeeper" and have significant responsibility for verifying the product before it circulates.

The importer's obligations include:

• Placing Only Compliant Devices on the Market: Importers must ensure they only place MDR-compliant devices on the EU market.
• Verify Compliance: Before placing a device on the market, they must verify that:
  • The device is CE-marked and an EU Declaration of Conformity has been drawn up.
  • A manufacturer is identified and an AR has been designated.
  • The device is labeled in accordance with the regulation and accompanied by the required instructions for use.
  • A UDI has been assigned by the manufacturer, where applicable.
• Provide Identification: Indicate their name, trade name, and registered address on the device or its packaging, so their location can be established.
• Ensure Proper Storage and Transport Conditions: Ensure that while the device is under their responsibility, conditions do not jeopardize its compliance with safety and performance requirements.
• Report and Cooperate: Immediately inform the manufacturer and AR if they believe a device is non-compliant. If the device presents a serious risk, they must also inform the competent authorities.

4. The Distributor: The Final Link in the Chain of Custody

A distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market up to the point of putting it into service. They are the final link ensuring the product's integrity before it reaches the end-user.

Key obligations of the distributor include:

• Act with Due Care: Before making a device available, distributors must verify that it is CE-marked, has an EU Declaration of Conformity, is accompanied by the necessary information from the manufacturer, and that the importer (if applicable) has complied with requirements.
• Ensure Proper Storage and Transport Conditions: Comply with the conditions set by the manufacturer while the device is under their responsibility.
• Cooperate and Report: Inform the manufacturer, AR, and importer if they believe a device is non-compliant. They must cooperate with competent authorities and maintain a register of complaints, non-conforming devices, recalls, and withdrawals.
• Support Traceability: Cooperate with manufacturers or authorised representatives to achieve an appropriate level of device traceability.

When Roles Blur: The Crossover of Responsibility

A critical point clarified by the MDR is the set of circumstances under which an importer, distributor, or another person assumes the obligations of a manufacturer. This occurs when they:

• Make a device available on the market under their own name, registered trade name, or registered trademark (unless an agreement is in place identifying the original manufacturer).
• Change the intended purpose of a device already on the market.
• Modify a device already on the market in such a way that compliance with the applicable requirements may be affected.

Understanding this boundary is vital, as it can inadvertently place a company in the legal position of a manufacturer with all the associated obligations.

Conclusion: Compliance is a Shared Effort

The MDR has created a system of interlocking responsibilities where patient safety does not depend on a single party. From the manufacturer setting the foundation, the AR acting as a legal bridge, the importer controlling market entry, to the distributor ensuring integrity at the final stage, each Economic Operator is an indispensable link in the chain.

At ITR, we not only provide product development services from concept to market but also act as your strategic partner to navigate this complex regulatory landscape. Whether you are a startup seeking a path into the EU or an established company with a CE mark looking to expand to other markets like the US with FDA approval, our expert team is ready to assist. We help build the technical file, conduct clinical evaluations, and establish robust QMS, ensuring that not only your product but your entire supply chain meets the highest standards.

‍