HANDLING MEDICAL PRODUCTS IN ACCORDANCE WITH THE PROVISIONS OF MINISTERIAL DECISION 1348/2004
What is M.D. 1348/2004 and who is concerned?
The Ministerial Decision (MD) 1348 concerns the companies who market and sell medical devices and it outlines the principles and guidelines of distribution for those products.
From the provisions of the MD, the manufacturers are exempted if they only sell products of their own production.
Therefore it aims to retailers of medical devices, to companies that in any way convey or store medical products, but also to manufacturing companies who market and sell medical products of other manufacturers.
The growth of the requirements of the MD 1348 is largely based on both the EU Directive 93/42/EEC and international standards ISO 9001 and ISO 13485, isolating the requirements for handling, storage and distribution of products.
What is the role of IDEC S.Α.?
Give the long experience in management systems and business consultancy, IDEC has the necessary expertise to develop a system based on the standard’s requirements. The services of IDEC include the following:
- Diagnostics studies to identify the shortages of the company based on the requirements of the standard.
- Specification of action plan. Registration and confirmation of system processes.
- Staff training.
- Carry out internal audits to confirm proper maintenance of the system.
- Presence and support during the external audit by the Certification Body.
- Completion of non-conformities that may arise.
- Support the company after its certification by conducting internal audits and providing consulting services.