Compliance

It is every employees’ responsibility to bring violations and suspected violations of our Code of Conduct and other standards to the company’s attention. Employees at all levels are prohibited from retaliating against or threatening anyone for reporting or supplying information about a policy or conduct concern.

Medtronic’s Compliance Office receives and processes all ethics and compliance complaints. Complaints relating to Medtronic's accounting, internal accounting controls, or auditing are referred to members of the Audit Committee. Concerns also may be referred to the Lead Director of the Medtronic Board at leaddirector@medtronic.com.

Whenever our Office of Ethics and Compliance receives reports of suspected misconduct or discovers a violation, the matter is recorded, a case is opened, and key personnel are notified of the matter. All cases are investigated. If evidence proves that the allegation is true, the company takes appropriate disciplinary action, up to and including the termination of employment. Periodically, we share the nature, status, resolution, and any resulting corrective actions related to each reported matter with senior leadership and the Audit Committee of our Board of Directors.

Clinical and Regulatory Compliance

Medtronic products are heavily regulated by governmental agencies, health ministries, and other regulatory authorities worldwide. As such, employees are responsible for complying with product regulation requirements, wherever we do business, related to marketing approvals, conduct of clinical studies, good manufacturing practice requirements and standards, design controls, labeling and advertising controls, and any other product regulations and controls promulgated by government agencies.

We require employees to report any possible violations to management and/or Medtronic’s Chief Regulatory Officer. Medtronic is committed to maintaining an open, constructive and professional relationship with regulators on matters of regulatory policy, submissions, compliance, and product performance.

Customs Compliance

Likewise, Medtronic is committed to full compliance with all applicable customs laws and regulations of the United States and other countries in which we conduct business. These include U.S. export controls, economic sanctions, and anti-boycott programs.

At the close of fiscal year 2010, our Operations Import and Export Compliance Departments merged to form the International Trade and Customs Compliance Department. The new department implements and manages our Global Customs Compliance Program and partners with our business units to create a global customs compliance culture. A newly launched internal web site provides employees with a single source for detailed information on policies and procedures, work instructions, and training materials related to export and import, including the proper handling of hazardous materials.