Representation Agreements: Defining Scope and Authority

A representation agreement should define far more than a job title. Clearly assigning authority, responsibilities, and communication processes helps prevent operational and regulatory confusion.

Representation Requires Clearly Defined Authority

A representation relationship should not be defined only by a role title. Terms such as U.S. Agent, Initial Importer, regulatory representative, or commercial representative describe functions, but they do not by themselves establish what the representative may communicate, decide, sign, retain, or commit on the manufacturer’s behalf.

Those boundaries should be settled before the relationship becomes operational.

Define Communication Responsibilities

The agreement should identify the communications the representative is expected to receive and manage. This may include correspondence from FDA or other authorities, import questions, distributor inquiries, complaints, Medical Device Reporting escalations, inspection notices, recall communications, and requests requiring a manufacturer response.

It should also define response times, approved communication channels, required escalation points, and whether the representative may answer directly, transmit information only, or coordinate a response prepared by the manufacturer.

Clarify Record Ownership and Access

Record responsibilities require equal precision. The parties should specify which records the representative creates or maintains, who owns them, how long they are retained, when the manufacturer may inspect or obtain copies, and how records will be transferred at termination.

A manufacturer should not discover during an inspection, complaint investigation, transaction, or provider change that essential correspondence and operational history are inaccessible or divided among several parties.

Address Routine and Event-Driven Fees

Fees should address more than an annual appointment charge. Agreements may need to distinguish routine service fees from event-driven work, government charges, customs expenses, third-party costs, travel, inspection support, complaint activity, recall execution, and extraordinary regulatory response.

Clear fee mechanics reduce disputes precisely when rapid action is required.

Separate Administrative Authority From Decision Authority

Indemnities, liability limitations, and insurance provisions should reflect the actual allocation of responsibilities. They should not obscure each party’s duties or be treated as transferring obligations that applicable law assigns to a particular party.

The agreement, or an appended authority matrix, should distinguish administrative authority from decision authority.

A representative may be permitted to submit information, acknowledge receipt, coordinate stakeholders, or execute pre-approved actions without being authorized to change labeling, admit liability, initiate a recall, accept a regulatory position, settle a complaint, or bind the manufacturer commercially.

Plan for an Orderly Transition

Termination provisions should address notice periods, immediate termination events, open matters, unpaid fees, regulatory notifications, successor appointments, continued cooperation, and the orderly transfer of records.

Representation should not end operationally before responsibilities have been reassigned and critical communications can continue without interruption.

Connect Representation With U.S. Operations

MDD Options structures representation arrangements around the work that must actually be performed.

Depending on the engagement, this can include U.S. Agent services, Initial Importer functions, import coordination, complaint and recall communications, record control, escalation procedures, and defined decision pathways.

Its Hybrid model can also connect representative responsibilities with U.S. distribution operations, while consulting support can help manufacturers assess scope, authority, risk allocation, and transition requirements before signing or replacing an agreement.