MEDICAL DEVICES SHIPPING
Shipping medical devices for processing and trials involves a complex regulatory framework, particularly under the EU’s Medical Device Regulation (MDR) 2017/745 and In Vitro Diagnostic Medical Device Regulation (IVDR) 2017/746. These regulations impose strict requirements on relabeling, repackaging, and translating device information to ensure compliance, which is essential for smooth cross-border medical device shipping.
In this blog we will go through the following topics:
MDR/IVDR Article 16
The EU’s Article 16 of MDR/IVDR defines actions that distributors and importers can take—such as relabeling or repackaging—without assuming manufacturer obligations, provided they meet regulatory compliance standards. For businesses involved in medical device shipping, adhering to these guidelines is critical for effective and compliant distribution.
Activities Allowed Under Article 16
- Translation of Device Information: Importers and distributors may translate the manufacturer’s information, including labels and instructions, to meet language requirements in EU Member States.
- Packaging Modifications: To align with market needs, companies may adjust outer packaging, such as resizing for specific healthcare requirements. These adjustments are allowed as long as they maintain the device’s compliance.
Repackaging and Relabeling
To meet Article 16 standards, importers and distributors involved in shipping medical devices must ensure:
- Notification: Notify the manufacturer and the competent authority 28 days before introducing a relabeled or repackaged device. This notification should include samples to verify compliance.
- Certification: Obtain certification from a notified body to confirm compliance with MDR/IVDR standards, especially for repackaging and relabeling.
- UDI and Traceability: Preserve the device’s Unique Device Identification (UDI) and traceability to maintain regulatory standards and safeguard essential information.
- Quality Management System (QMS): Implement a QMS to document and trace all procedures, supporting field safety and post-market surveillance.
Additional Considerations for Medical Devices Shipping
- Streamlined Notifications: Notify only once for initial market introduction; batch-by-batch notifications aren’t necessary unless significant changes are made.
- Post-Market Obligations: Continued communication with manufacturers and authorities, even if relabeling or repackaging has ceased, enhances transparency for post-market monitoring.
Practical Example
An importer may receive syringes in bulk and repackage them into smaller batches to meet local healthcare provider needs. Provided the primary sterile packaging remains intact, this practice aligns with Article 16 without adding regulatory obligations.
Shipping medical devices within the EU requires a comprehensive understanding of MDR/IVDR regulations.
At Customs Complete, we specialize in compliant medical device shipping to support efficient and effective cross-border distribution. Contact us for assistance with your logistics and regulatory compliance needs.
