Cairo, Egypt 29 October 2025 —- The Egyptian Drug Authority (EDA) has issued a significant regulatory update concerning the import of Procedure Packs under the EU Medical Device Regulation (MDR) 2017/745. This announcement provides essential clarity for manufacturers and importers when a Certificate of Free Sale (CFS) is not available from a reference country for such packs.
BACKGROUND: WHAT ARE EDA PROCEDURE PACKS?
Under EU MDR 2017/745, a Procedure Pack refers to a combination of CE-marked medical devices, assembled and packaged together for a specific medical purpose. While the pack as a whole may not always be commercially available in the reference country, its components often are. However, some manufacturers have faced challenges when reference countries do not issue a CFS for the full pack — mapping complications for import clearance in markets like Egypt.
EDA’S NEW DOCUMENTATION REQUIREMENTS FOR MEDICAL DEVICE REGISTRATION IN EGYPT
In the absence of a CFS for the full Procedure Pack, EDA now mandates submission of the following individual and pack-level documentation:
- Certificate of Free Sale (CFS) for each individual medical device included within the Procedure Pack
- CE Certificate for each individual medical device included within the Procedure Pack
- Declaration of Conformity for the Procedure Pack as per Article 22 of EU MDR 2017/745
- ISO 13485:2016 Certificate of the actual manufacturer of the medical devices
This regulatory move is designed to ensure traceability, compliance, and adherence to international standards, even in the absence of a consolidated CFS for the full pack.
HOW DOES THIS IMPACT ON MANUFACTURERS (PROCEDURE PACK RULES)?
1. Increased Documentation Burden
Even though the Procedure Pack itself may not receive a CFS, manufacturers must ensure:
- Each component device has its own CFS and CE Certificate
- The Procedure Pack assembler (if different from device manufacturers) provides a Declaration of Conformity under Article 22.
This places responsibility on both:
- Original device manufacturers (for individual certifications)
- Procedure pack assemblers (for Article 22 compliance)
2. Implications for Market Access in Egypt
Manufacturers exporting to Egypt need to pre-validate their documentation strategy:
- If a CFS is unavailable for the full Procedure Pack (e.g., because it’s a customized kit or non-commercial combination), they must proactively collect documents for each component.
- Failure to do so will result in delays or denial of registration/import clearance with the EDA.
3.Strategic Planning for Market Access
Without a CFS for the full Procedure Pack, entry into Egypt now requires robust document coordination between manufacturers, assemblers, and local importers.
REGULATORY REFERENCE
This update aligns closely with EU MDR Article 22, which governs the assembly of Procedure Packs and system configurations. For full compliance, stakeholders are advised to revisit their documentation strategies and internal quality systems.