Risk Classification in Morocco: Four Classes and Five Criteria

1. Key takeaways

Under Article 4 of Loi n° 84-12, Morocco divides medical devices into Class I (potentially low risk), Class IIA (potentially medium risk), Class IIB (potentially high risk) and Class III (potentially very high risk). The classification rests on five criteria: the duration of use, whether the device is invasive, whether the intended use is surgical, whether the device is active, and whether it acts on vital organs or systems such as the circulatory system and the central nervous system. Each device receives exactly one class, and that single letter-and-number combination drives a surprising share of the project economics. The class determines the depth of the administrative and technical dossier that Article 14 will require, and it also sets the tier of the fine structure under Articles 43 and 44 if anything later goes wrong on the market. Classification is therefore not a preliminary formality to be settled quickly; it is the starting point of the cost model for the entire Moroccan project, and an error here propagates into the dossier, the budget and the liability exposure simultaneously.

2. Legal basis

Two instruments carry the classification regime: the article of the law that establishes the four classes and their criteria, and the ministerial order that operationalizes the rules in practice.

Terminology note: the statute writes the second and third classes as “classe II A” and “classe II B” with a space; this series uses the compact forms Class IIA and Class IIB throughout.

3. Expert insights

Insight 1: Article 4 gives principles and class names; the working rules sit in the ministerial order. The article lists the five criteria and the four classes, but it provides no European-style classification decision table. The operative rules are carried by Arrêté n° 2856-15, and in practice the class recorded on the manufacturer’s CE certificate is an important reference point. The working practice verified by GRZAN is that AMMPS registers the device at the class stated on the manufacturer’s CE certificate. For CE-marked products this simplifies intake considerably; for products without a CE certificate, the absence of the certificate removes the anchor and the class must be argued from the criteria alone, which makes the written reasoning in the dossier substantially more important.

Insight 2: Classification is not an academic question; it is the basis for calculating fines. Under Article 43, the fixed fine range for Class I and Class IIA establishments is MAD 200,000 to MAD 500,000. For Class IIB and Class III establishments, the same provision instead imposes a fine calculated at 2% to 5% of the establishment’s turnover in Morocco for the last completed fiscal year, excluding tax, with a floor of MAD 500,000. Article 44 goes higher still: for Class IIB and Class III establishments, the fine is calculated at 7% to 10% of turnover, with a floor of MAD 1,000,000. A device that is classified one tier too low feels cheaper on filing day, but if an incident occurs, the penalty calculation switches to the turnover-based scales that were designed precisely to outweigh any savings from under-classification.

Insight 3: Three common misclassifications recur in practice.

• Misjudgment 1: treating an ordinary Class I device that is non-sterile and non-measuring as requiring no action at all. Article 12 grants no registration exemption for Class I; only the depth of the dossier differs by class.
• Misjudgment 2: copying the class from the Chinese registration certificate. Chinese Class 1, 2 and 3 do not map one-to-one onto the Moroccan Class I, IIA, IIB and III; the five Article 4 criteria must be re-applied to the device on its own terms.
• Misjudgment 3: inferring a high class from the word sterilization. Under European rules, medical sterilizers fall in Class IIA, with higher classes reserved for invasive-use disinfectants and washer-disinfectors; copying a product name without reading its intended use produces the wrong class.

4. Practical recommendations

1. Anchor on the CE certificate, cross-check against Article 4. For CE-certified products, take the class from the certificate, then re-run the five Article 4 criteria once as a verification step, recording both results in the classification memorandum.
2. Without a CE certificate, argue equivalence. For non-CE products, establish the class of an equivalent device first and explain the reasoning in the dossier rather than presenting a bare assertion.
3. Have the classification memorandum answer why not a higher class. Authority questions typically arise from suspected under-classification, so preparing the counter-argument in advance materially raises the chance of a single-pass review.
4. Sync the classification outcome with the dossier tier. If the class changes, the administrative and technical document ranges required by Article 14 change with it, and the document list and budget must be re-cut at the same time.

5. Verification checklist

• □ The reasoning for each of the five Article 4 criteria has been recorded item by item
• □ The CE certificate has been obtained and the class stated on it has been checked
• □ The class notation is uniform as Class I, IIA, IIB or III
• □ The administrative and technical document range corresponding to the class has been confirmed
• □ The penalty tier for this class under Articles 43 and 44 has been assessed
• □ The classification memorandum states why no higher class applies
• □ The classification outcome has been propagated to the dossier list and the cost budget

Regulatory information verified as of October 30, 2026. GRZAN provides classification analysis, risk-class argumentation and registration dossier preparation for manufacturers entering Morocco under Loi n° 84-12 and Arrêté n° 2856-15. For project inquiries, contact info@grzanglobal.com.