Materiovigilance in Morocco: The 48-Hour Incident Reporting Rule

1. Key takeaways

Article 24 of Law No. 84-12 establishes the national materiovigilance system, whose task is to monitor incidents or risks of incidents arising from the use of devices after they have been placed on the market. Article 25 requires the heads of manufacturing, import, export and distribution establishments, together with healthcare professionals who use devices, to report to the competent authority, within 48 hours of becoming aware of them, any incident or risk of incident, as well as any failure or deterioration in quality. Failure to report falls within the heavy penalties of Article 44. Two practical consequences follow immediately. First, the reporting obligation is not limited to harm that has already occurred: a credible risk of an incident starts the same clock. Second, the deadline runs from the moment of awareness, not the moment of occurrence, so the way a company captures complaints internally becomes a compliance variable in its own right. Manufacturers serving the Moroccan market should treat both features as fixed design constraints of their post-market vigilance workflow.

2. Legal basis

3. Expert insights

Insight 1: the reporting scope covers “an incident or a risk of incident”, not only adverse events that have occurred. Article 24 and Article 25 both use the wording “incident ou risque d’incident”. This means that potential risks are within the reporting scope, and a company cannot decline to report on the ground that no harm has yet been caused. In practice, the safest internal rule is to treat any credible risk signal — a near miss, a malfunction that could plausibly lead to harm, an anomalous trend in complaint data — as reportable unless a documented assessment concludes otherwise.

Insight 2: the reporting subjects cover the entire chain. Article 25 lists four categories of establishment heads — manufacturing, import, export and distribution — plus healthcare professionals who use devices. This is a rare feature of the Moroccan system: healthcare facility staff are placed directly under a reporting duty, which means vigilance information can reach the competent authority through two independent channels, the regulated trade side and the clinical side. Companies should not assume that silence on the distributor side means silence everywhere.

Insight 3: the starting point is “awareness”, not “occurrence”. The provision refers to events “dont ils ont pris connaissance” — of which they have become aware. This settles the attribution question for delayed information flow, but it also obliges companies to define clear internal rules on when awareness is deemed to arise: the moment a salesperson, a customer-service agent or a technical-support engineer receives a complaint may already start the 48-hour clock. Companies distributed across time zones and distributor networks face this issue constantly, since the person who first hears about an event is rarely the person who prepares the report.

Insight 4: quality deterioration must also be reported. The provision places “any failure or deterioration in quality” (toute défaillance ou altération de la qualité) on the same footing as incidents. Even where no clinical consequence has occurred, an abnormality in the product itself is reportable. Manufacturers whose quality systems only classify events by patient harm will need to widen their Moroccan reporting criteria accordingly.

Insight 5: failure to report is expressly listed in Article 44. Article 44 includes “failure to report under Article 25” among the turnover-based penalties: Class I and Class IIA devices face 5% to 7% of turnover (floor of MAD 700,000), and Class IIB and Class III devices face 7% to 10% (floor of MAD 1,000,000). This is one of the most expensive compliance risks of the entire post-market phase, and it attaches to an obligation that is easy to breach accidentally when complaint intake is fragmented across departments or distributors. The fine is calculated on turnover, so even a single missed report on a high-revenue device line can reach the statutory floor very quickly.

Insight 6: the organization and operation of the system are set by regulation. The second paragraph of Article 24 provides that the organization and operation of the national materiovigilance system are determined by regulatory text. Companies need to track that companion text to obtain the concrete requirements for report forms and reporting channels, because the law itself stops at the principle and the deadline. Until that text is issued, the 48-hour deadline and the broad reporting scope of Article 25 remain the operative constraints, and they are already enforceable through the Article 44 penalties.

4. Practical recommendations

1. Build the 48 hours into a process, not a reminder. Establish a standardized channel from complaint receipt to submission to the competent authority, including translation, review and filing stages, and compress the whole flow to fit within 48 hours.
2. Define the rule for when “awareness” arises. State in your procedure that the moment sales, customer-service or technical-support staff receive the information counts as company awareness, and set an internal escalation deadline (a practical estimate is no more than 8 hours).
3. Write the reporting criteria broadly, not narrowly. Explicitly include “risk of incident” and “deterioration in quality” in the internal reporting standard to avoid under-reporting.
4. Divide reporting duties with the license-holding establishment. The obligation under Article 25 covers both manufacturing and import establishments; the agreement should specify who reports, who assists, and how quickly information is exchanged between the parties. Without that allocation, a complaint received by one party may sit outside the other party’s awareness clock until the 48 hours are nearly spent.
5. Retain all reporting records. Keep a vigilance log recording the event description, the time of awareness, the time of submission and the receipts, so the file is ready for inspections conducted under Article 38.

5. Verification checklist

• □ A standard 48-hour reporting procedure with named owners has been established
• □ Internal rules for determining the moment of “awareness” have been documented
• □ The reporting standard covers “risk of incident” and “deterioration in quality”
• □ Reporting duties between the license-holding establishment and the manufacturer have been allocated in the agreement
• □ A vigilance log exists, recording awareness times and submission receipts
• □ French-language report templates are ready for use
• □ The penalty tier for non-reporting under Article 44 has been assessed

Regulatory information verified as of October 30, 2026

Post-market support from GRZAN. GRZAN helps medical device manufacturers and importers serving the Moroccan market manage their post-market compliance obligations, including materiovigilance reporting within statutory deadlines, recall and withdrawal execution, and preparation for inspections and enforcement actions. Our team builds the reporting workflows, vigilance logs and escalation rules described above, and keeps them aligned with the Moroccan regulatory texts. For support with materiovigilance and post-market surveillance in Morocco, contact info@grzanglobal.com.