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Importing Medical Devices Into the United States

Emre Aykac
Importing Medical Devices Into the United States

The European medical device (MD) market is estimated to be worth around €140 billion. It is the second biggest MD market in the world, covering 27.6% of the world market, behind only the United States. This should be encouraging to medical device companies to consider exporting their products to the European Union (EU).

Considerations When Shipping Medical Devices to Europe

The first step to export medical devices logistics to Europe is to comply with regulatory requirements. Compliance is determined through the CE mark. It indicates that the manufacturer complied with European standards of safety, health, and environmental protection.

CE marking can be obtained as follows:

1. Classification

Medical devices are divided into four classifications (Class I, Class IIa, Class IIb, and Class III) based on risk and intended use—the higher the risk, the higher the Class.

2. Quality Management System

Medical device manufacturers must have a Quality Management System (QMS) in accordance with Annex II or V of the Medical Devices Directive (MDD). QMS compliance is based on ISO 13485, which specifies requirements for an organization to demonstrate its ability to manufacture medical devices that meet customer and regulatory requirements.

3. Technical Documentation

Technical documentation indicates conformity and must include all prurient details such as device description, manufacturing information, safety requirements, risk management, and more.

4. Authorized Representative

The manufacturer must authorize an EU representative that will be their liaison to the European Ministry of Health.

5. Declaration of Conformity & CE Marking

When conformity assessment is done, the manufacturer will sign the EU Declaration of Conformity. After this, the CE mark can be affixed on the device.

6. Labeling

The EU comprises 31 countries and 23 official languages. Labeling of MDs, instructions for use, and documentation must be done in the Member State’s official language. The translation should comply with national regulatory requirements.

7. Shipping and Import

Before manufacturers ship their products, they must designate an official importer from the EU. The importer is officially the entity that will purchase the medical device from the manufacturer and sell it to local distributors or end-users.

Importers must register with EUDAMED or the European Database on Medical Devices.

8. VAT and Import Duties

The EU implements an average value-added tax (VAT) rate of 21%. However, due to the COVID-19 pandemic, VAT and custom duties are currently suspended in the EU. The waiver will be implemented until June 30, 2022.

9. Logistics and Storage

According to Medical Device Regulations (MDR), it is the importer’s responsibility to ensure that logistics—including transportation of medical devices—conform to safety standards and will uphold the quality of the products.

The storage facility should also comply with standards indicated under the MDR.

Emre Aykac
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