Ministerial Decision Δ3(α)4822
System of Principles and Guidelines for Good Distribution Practice of Medical Devices
QLC’s certification consultants answer your questions
Ministerial Decision Δ3(α) 4822 (Government Gazette 1197/B/12.3.2005) sets out the requirements for maintaining a system of principles and guidelines related to Good Distribution Practice of medical devices, ensuring that products are not compromised and their quality is not degraded.
All businesses, regardless of their legal form, whose turnover includes the import, distribution, intra-community trade, and export of medical devices—either exclusively or in combination with other activities, are obligated to comply with the Ministerial Decision. Excluding manufacturers of medical devices
Developing the system involves the following phases:
- Categorizing the products being distributed; checking the completeness and validity of related accompanying documents; and defining how to rectify any deviations
- Evaluating the compliance of existing processes and records with the requirements of the Ministerial Decision
- Reviewing existing processes and records where deviations from the Decision’s requirements exist, and introducing new processes and records where they are completely absent
- Training personnel in the system’s requirements
- Implementing the system
- Reviewing and modifying the system as necessary
- Conducting an internal audit
Factors that may affect the degree of difficulty in implementing this system include the size of the business, the variety and categories of the products, the complexity of the processes, and the staff’s familiarity with maintaining a quality system.
Working with a specialized consultant is considered essential to develop a functional and effective system tailored to the company’s needs, fulfilling legal requirements and ensuring product quality.
The Ministerial Decision can also be combined with other management systems the company may already apply or intends to apply, such as ISO 13485 or ISO 9001, enabling the establishment of a unified management system.
Compliance with the Ministerial Decision is confirmed through inspections by Notified Bodies in the field of medical devices. The inspection process involves evaluating the company’s compliance with legal requirements for distributing medical devices, assessing the system against the Decision’s requirements, and reviewing its practical application.
Upon successful completion of the inspection, the Notified Body issues a Certificate of Conformity (valid for three years). If there are significant deviations, corrective actions must be taken by the company before the Certificate can be issued. For minor deviations, the company must carry out corrective actions before the next inspection.
The Certificate remains valid as long as scheduled periodic inspections are performed by the Notified Body—at least annually—confirming ongoing compliance with the specified requirements.
The main reason to comply is the legal obligation for all medical device distributors to have a Certificate of Conformity for the principles and guidelines system used in distributing their products. Additional reasons include:
- Developing business transactions with customers or suppliers seeking partnerships with companies that comply with the Ministerial Decision
- Eligibility to participate in public tenders, where the Certificate of Conformity is included among the required documents
- Organizing departments and standardizing processes to minimize errors and failures
- Improving staff performance
The time required to develop the system and obtain the Certificate depends on factors such as the size of the business, the level of organization, the degree of compliance with legal requirements, and staff involvement. For small businesses that already meet legal requirements, it usually takes between 1 and 4 months.