What are these requirements?
- Exercise due care when carrying out distribution activities.
- Before making a medical device available on the market, verify the following:
- The device has an EU Declaration of Conformity and CE marking.
- The required information is provided with the device, either on the packaging or in the Instructions for Use (IFU)
- Where applicable, a Unique Device Identifier (UDI) has been assigned.
- For imported devices, the requirements of Article 13 have been fulfilled.
- Ensure that medical devices are stored and transported under appropriate conditions.
- If there is reason to believe that a device is not in conformity with the regulations, immediately inform the manufacturer, authorized representative/importer, and competent authority, and cooperate with investigations and corrective actions.
- Report (suspected) incidents to the manufacturer, authorized representative/importer, and competent authority. Distributors must maintain a register of complaints, non-conforming devices, recalls, and withdrawals.
- Upon request, provide competent authorities with all information and documentation necessary to demonstrate device compliance.
Additional Belgian Requirements
In addition to the European requirements, distributors operating in Belgium must also comply with specific national obligations.
Distributors must register with the Belgian Federal Agency for Medicines and Health Products (FAMHP/FAGG) and comply with the guidelines entitled “Good Distribution Practices for Distributors of Medical Devices” issued by the agency.
These guidelines describe the requirements for a quality system across nine chapters, covering:
- Requirements relating to the quality system, personnel, and documentation.
- Requirements for premises used to store medical devices.
- Documentation and controls required for the execution of distribution activities.
- Procedures for handling returns, complaints, and recalls.
What records and procedures are required?
- Materiovigilance procedures, including the handling of product complaints.
- Requirements to consider when activities are outsourced.
- The performance and documentation of internal audits.
By Hadewych Van Brecht
