Medical Device Distribution

Medical Device Distribution


Medical devices span a wide range of products. It is used by many people, from the general public to the most critically ill patients treated in clinical settings. The quality and performance of medical devices directly affect the safety and health of patients. Among the patients using the device are people from all walks of life, such as newborns and infants, the elderly and the disabled. In addition, among these patients, there are also groups that are more susceptible to various diseases and therefore extremely vulnerable.

The procurement, use and post-use process of medical devices are critical. Because many medical products may be exposed to inappropriate storage, undesirable and in some cases potentially serious consequences throughout the supply chain. In addition, the hygiene, safety and quality of medical devices are among the issues to be considered, as they are also used in high-risk surgical procedures and intensive care settings. This makes it necessary to open a separate parenthesis on the issue of medical device distribution and to carry out regulatory, preventive and remedial activities in this regard.


Medical Device Distribution Applications


All businesses, public or private sector organizations involved in the procurement process of medical devices have legal responsibility in all of their activities. For this reason, transportation, storage, testing of medical devices, training of personnel responsible for these devices, documents that need to be arranged and followed, etc. become important. In this context, a quality system should be established for medical device distribution applications and all studies should be carried out within the framework of this system. In this context, the following activities become inevitable:


• Quality management
• Staff education
• Documentation and record keeping
• Medical device receiving, storage and procurement processes
• Management of returned medical devices
• Counterfeit medical devices
• Recall and recall of medical devices
• Outsourced activities
• Transportation


Distributors must have a comprehensive and adequate quality system in order to meet regulatory requirements and ensure that only regulatory medical devices are available for supply. An effective quality system;

• execution of medical device distribution transactions in accordance with the law,
• detecting inappropriate, faulty or damaged medical devices,
• maintaining traceability,
• providing necessary controls to identify non-compliances and implement changes,
subjects can be secured.

The quality system that is actively implemented in the distribution of medical devices is the responsibility of the management of the organization. This system requires leadership and active participation, and must be supported by the commitment of staff. A person with clear authority and responsibility should be appointed by the organization´s management to ensure the implementation and maintenance of the quality system. All medical device distribution activities need to be clearly defined and systematically reviewed. For this, a written quality manual or a similar document should be created. All critical steps and significant changes in the medical device deployment process should be justified and validated as needed.



Medical Device Distributors (Distributors)


Distributors are responsible for verifying that the medical devices they sell meet the defined requirements. In addition, it should check whether the medical devices are CE marked and have a valid declaration of conformity. They must also ensure that the product´s instructions for use and labels are in the official language of the countries where the product is sold.

It should also be checked whether the imported medical devices meet the importer´s requirements. In this way, distributor companies also undertake the necessary responsibility for the suitability of the products they sell. Although a medical device is produced correctly and offered for sale by distributor companies, if the distributors detect a problem regarding compliance, the product is not allowed to be put on the market.

One of the most comprehensive legislation on medical device distribution is the Medical Device Regulation (Regulation (EU) 2017/745). This regulation makes distributors a control authority in many points in the distribution of medical devices. In this context, distributors are obliged to inform the authorities in case the product breaks down, malfunctions or poses a serious risk. At this point, not selling the product is not enough, it is inevitable to notify the authorities. In addition, distributors must keep records of medical device complaints, recalls and recalls.


Medical Device Distribution and Your Solution Partner Aşan Danışmanlık


Acceptable for any non-commercial use or use in medical applications. These improvements, dissemination and world-wide regulations, have to be good and should be. In this regard, to be experienced in education and training on a medical device. In case of a problem in the distribution processes, you can immediately get detailed information from Aşan Danışmanlık.