Certification of Ministerial Decision 1348

Ministerial Decision 1348 - Principles and guidelines of good practice of distribution of medical devices in accordance with the requirements of Ministerial Decision 1348/2004

Target Group

The standard applies to any business of Trading & Distribution of Medical Technological Products, regardless of legal form and size..

What is Certification of Ministerial Decision 1348

The Ministerial Decision 1348/2004 sets out the requirements for the observance of a system of principles and guidelines regarding the good practice of distribution of medical devices so that the products are not altered and their quality is not degraded by the moment they are received by the supplier until the moment they are delivered to the customer.

"Medical device" (Directive 93/42 / EEC) concerns any instrument, apparatus, equipment, material or other, used either exclusively or in parallel with any other activities, including the software required for its proper operation, intended by the manufacturer to be used in humans for:

Diagnosis, prevention or curament
Diagnosing, monitoring, treating, relieving or curament of trauma or disability
Researching or modifying the anatomy of a normal function

Certification Process / Required documents

The company that is interested in being certified according to the requirements of Ministerial Decision 1348, should contact BQC and fill in certification application and send it to This email address is being protected from spambots. You need JavaScript enabled to view it.or fax it to 2112213726

Why choose BQC

BQC is accredited by the Hellenic Accreditation System (ESYD), issues internationally recognized Certificates, and cooperates with experienced inspectors and experts from all over the world, ensuring the most updated and professional knowledge in any business sector.