MD 1348:2004 concerns the Good Distribution Practice (GDP) of Medical Devices and is the main regulatory framework for companies involved in the import, storage, distribution and trading of medical devices in Greece.
- Addresses companies of medical devices, consumables, healthcare materials and related products.
- Required for collaborations with hospitals, clinics, medical warehouses etc.
- Strengthens product safety, traceability and compliance with EOF requirements.
Compliance with MD 1348:2004 demonstrates that the company has established procedures ensuring proper storage, handling, traceability and product recall of medical devices, safeguarding their quality and safety.
Key points of MD 1348:2004:
- ✓ Organizational structure & responsibilities for product distribution
- ✓ Suitable storage & transport conditions
- ✓ Procedures for receipt, inspection & distribution
- ✓ Traceability of batches & recall procedures
- ✓ Documentation & record keeping
Compliance with MD 1348:2004 strengthens the company’s credibility before Public Authorities and EOF, as well as partners and clients in the healthcare sector.
Implementation of MD 1348:2004 in Your Company
The Investment Center undertakes the complete preparation and organization of procedures so your company fully complies with MD 1348:2004 and can successfully pass inspections or certification.
- Assessment of current status, facilities & distribution flows.
- Design & development of procedures according to MD 1348:2004.
- Preparation of Manuals, Procedures & forms (e.g., receipts, storage, shipments).
- Traceability procedures, complaint handling & product recall management.
- Staff training for daily implementation of requirements.
- Internal audit & preparation for inspection by authorities/bodies.
Request an Offer for MD 1348:2004 Compliance
Full support for warehouses, distributors & traders of medical devices.
The Investment Center has long-standing experience in certification and compliance projects for medical device companies under MD 1348:2004, as well as standards such as ISO 9001, ISO 13485 and ISO 27001.
Detailed Information on MD 1348:2004
▲ Scope & Applicable Companies
MD 1348:2004 applies to companies engaged in the import, storage, distribution and trading of medical devices.
Indicatively, it concerns:
- Companies of medical devices & medical consumables.
- Trading companies of healthcare materials & hospital supplies.
- Warehouses & distributors supplying hospitals/clinics.
- Businesses participating in healthcare supply tenders.
▲ Main Requirements of MD 1348:2004
Main thematic areas of MD 1348:2004:
- Organization & staff responsibilities.
- Storage areas, cleanliness, temperature & humidity conditions.
- Procedures for receiving, storing, distributing & returns.
- Traceability system (batches, serial numbers, etc.).
- Complaint handling & adverse event reporting.
- Product recall procedures.
- Documentation, records & inspections by authorities.
▲ Benefits & Healthcare Partnerships
Compliance with MD 1348:2004 offers:
- Improved credibility & professional image in the healthcare sector.
- Eligibility to participate in hospital tenders & supply contracts.
- Reduced risks for patient/user safety.
- Better documentation during inspections or incidents.
▲ Implementation & Documentation Method
We follow a structured methodology, tailored to your operations, so that all requirements of MD 1348:2004 are met without excessive bureaucracy.
The phases include:
- Recording existing procedures & facilities.
- Gap analysis against MD 1348:2004 requirements.
- Design & development of Manual & Procedures.
- Staff training & trial implementation.
- Internal audits & corrective actions.
▲ Timeline & Inspections
The compliance timeline depends on company size and product flow complexity. It typically ranges between 1–3 months.
Documentation and implementation are inspected by the competent authorities (e.g. EOF) or by certification bodies, depending on the compliance model selected.
▲ Implementation & Compliance Cost
Cost depends on product volume, number of facilities, number of employees and any additional requirements (e.g., ISO 9001, ISO 13485).
We provide a detailed cost estimate after a short evaluation of your activities and compliance needs, ensuring full transparency before project initiation.
▲ Combined Standards & Other ISO Types Covered
MD 1348:2004 is often combined with:
- ISO 9001:2015 – Quality Management System.
- ISO 13485 – Quality Management System for medical devices.
- ISO 27001 – Information Security (especially for digital records & systems).
Other ISO types covered
ISO 14001:2015 Environmental Management System ISO 45001:2018 Occupational Health & Safety Management System ISO 22000 (HACCP) Food Safety Management System MD 1348 Good Distribution Practice of Medical Devices ISO 13485 Quality Management for Medical Devices ISO 27001 Information Security Management System
The Investment Center provides complete and integrated support for compliance with MD 1348:2004 and related standards. More information at 2108028330, 2118505001, (info@kei.gr).
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