Certification of Ministerial Decision 1348
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.

"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

Target Group

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

Certification Process / Required documents

The company that is interested in being certified according to the requirements of Ministerial Decision 1348 is kindly requested to contact the BQC and complete the certification application.

Why choose BQC?

BQC is a Certification Body with a wide activity in the health sector, both in Greece and abroad. The international prestige, specialized know-how and scientific training of BQC inspectors ensure the objectivity and impartiality of the inspections. Finally, for these reasons many Health Institutions choose BQC  as a partner for their certification.