Ministerial Decision (YA) 1348/2004 concerns the companies that trade and distribute medical devices and describes basic principles and guidelines of good practice of distribution of this type of products. The verification of the implementation of the law is done by the Certification Bodies.
The basic requirements of the legislation are the following :.
1. Defining procedures concerning the receipt, storage and distribution of medical devices and having properly trained the staff in them.
2. The appointment of a Responsible for the implementation process
3. Keeping records for the tracking of the product from its purchase to its delivery to the customer.
4. The temperature / humidity conditions provided by the manufacturer of the product must be observed in the storage areas, while measures must be taken to prevent leaks or breakage.
5. During the distribution of the product, the necessary measures should be taken for its integrity and the avoidance of its contamination.
6. For the return of medical devices, the current European legislation must be implemented.
PRIORITY has extensive experience in developing a system based on the requirements of Y.A.
Initially, a diagnostic study is performed where the findings of the company are identified based on the requirements of the legislation.
Then, written procedures are recorded and confirmed and the respective staff is training accordingly.
During the audit by the Certification Body, PRIORITY is present in order to help customer. The following years PRIORITY can support the company through execution of internal audits.
Do you want to discuss about your needs and provide you the right solutions?
Mrs. Lily Mylona,
Sales Director, PRIORITY
T. 210 2509900