MDSU Reporting Forms in Egypt: User Feedback, UIR and Manufacturer Incident Report

1. Key takeaways

The competent unit for medical device vigilance in Egypt is the Medical Devices Safety Unit (MDSU), whose external email address is pv.md@edaegypt.gov.eg. The form system is organised by reporting party. The User Feedback Form (Annex 1) is used by users to provide feedback to manufacturers. The User Incident Report (UIR, Annex 2) can be submitted by users directly to MDSU. The Manufacturer Incident Report (MIR, Annex 7) is submitted by manufacturers within the three-tier timeframes of 2, 10 and 15 calendar days. Each of the three forms has its own distinct role, and none can substitute for another.

2. Legal basis

The following provisions define the unit, the forms and the routes by which reports reach the regulator.

3. Expert insights

Insight 1: MDSU has a single external mailbox, which is the sole source of official submission credentials.

The guideline states that users may submit the UIR by email to pv.md@edaegypt.gov.eg in order to inform MDSU directly. Companies should designate this mailbox in their Egyptian vigilance SOPs as the unique official submission address, and should retain delivery receipts and timestamps as evidence of compliance with the statutory timeframes. Any other address is, at best, an informal channel.

Insight 2: the user feedback route and the incident reporting route are two different channels with different parties and consequences.

User feedback (Annex 1, separate from the UIR): users provide feedback to the manufacturer, sending it to the contact details stated on the label or to the place where the device was purchased, where staff ensure the feedback is forwarded to the manufacturer. User incident reporting (UIR, Annex 2): users submit directly to MDSU. The former is a commercial and quality feedback channel; the latter is a regulatory reporting channel with legal consequences for the manufacturer.

Insight 3: user feedback must not contain information that identifies the patient.

The guideline explicitly requires that no information that could lead to the personal identification of the patient be reported. This is a hard data-minimisation requirement, and any feedback form template a company designs for the Egyptian market must embed this constraint from the outset.

Insight 4: the duty to cooperate with MDSU extends in both directions.

The guideline encourages reporters to cooperate with manufacturers and MDSU in providing further information in two respects: regarding the incident itself, such as relevant results of internal investigations, and regarding the device or the patient outcome, such as a subsequent death. This means the first report is not the end of the process: changes in the outcome require supplementary reports.

Insight 5: record-keeping duties on the user side are written into the guideline.

The document feedback clause requires that users record, at any facility or site of use, any feedback relating to the use of a medical device, including the product name and product code of the affected device. Hospitals and clinics are therefore expected to maintain device feedback logs. For manufacturers, this has direct implications for channel management and for the quality of the information that eventually reaches them.

Insight 6: MDSU and the Egyptian Pharmacovigilance Center are two expressions of the same system.

The full wording in Section 8 of GL.CAMD.002 is Medical Devices Safety Unit – the Egyptian Pharmacovigilance Center, whereas GL.CAP.Care.040 consistently uses MDSU. Companies should use the corresponding expression in document headers and commitment letters depending on which guideline the document sits under, avoiding mixed usage that would complicate regulatory verification.

Insight 7: Annex 8 provides examples and can serve as a calibration tool for reportability decisions.

After the clauses on abnormal use and related matters, the guideline notes: For Examples: see (Annex 8). When determining whether a particular situation constitutes a reportable event, companies should first check it against the examples in Annex 8. As a practical estimate, the specific content of the examples should be confirmed against the current annex text of the guideline itself.

4. Practical recommendations

The following measures keep the form system and the mailbox aligned with daily operations.

1. Designate pv.md@edaegypt.gov.eg as the single official submission address and retain delivery receipts.
2. Select forms by reporting party: manufacturers use the MIR (Annex 7), users report directly via the UIR (Annex 2), and commercial feedback uses Annex 1.
3. Embed a no-patient-identifiable-information notice in feedback form templates.
4. Establish a mechanism for supplementary reports on subsequent outcomes, such as a later death.
5. Promote device feedback logs in the distribution channel, covering product name and product code.
6. Choose document expressions per guideline: MDSU or Medical Devices Safety Unit – Egyptian Pharmacovigilance Center.
7. Calibrate event determinations with the Annex 8 examples, and confirm in writing with MDSU where needed.

5. Verification checklist

• □ The official submission mailbox pv.md@edaegypt.gov.eg is written into the SOP
• □ The MIR (Annex 7) template is configured against the three-tier timeframes
• □ The UIR (Annex 2) and user feedback (Annex 1) routes are explained to the distribution channel
• □ Feedback forms embed a prohibition on patient-identifiable information
• □ A supplementary reporting mechanism for subsequent outcomes (such as a later death) is in place
• □ Channel-side feedback logs (including product name and product code) have been promoted and established
• □ Event determination criteria have been calibrated using the Annex 8 examples

Regulatory information verified as of October 29, 2026. The competent unit and form system listed in this article follow the current text of EDREX: GL.CAP.Care.040 Version 1 (published November 2025).

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