Importing Medical Devices Into the United States
The first step to export medical devices 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.
