Definition and Scope of Medical Devices under Moroccan Law 84-12

1. Key takeaways

Article 1 of Loi n° 84-12 provides 17 definitions, and Article 2 separately brings four categories of products into scope. To determine whether a product is a medical device under Moroccan law, the core test rests on two yardsticks applied together: intended use plus principal mode of action. A product qualifies as a device when the manufacturer designates it for a medical purpose on the human body and its principal intended action is not achieved by pharmacological, immunological or metabolic means. Both limbs must be satisfied for the product to fall inside the device regime, and both must be documented, because the authority will test them separately. Software is expressly written into the definition, and accessories follow the main device rather than standing on their own regulatory footing. In borderline work, these definitional anchors matter more than any comparison with other jurisdictions, because the Moroccan text draws its lines in its own way: products treated as drugs or borderline items elsewhere may still be captured here, and products captured elsewhere may fall outside if the mode-of-action test points the other direction. The classification exercise that comes later in the project is only as good as this definitional judgment.

2. Legal basis

Two instruments govern the question of definition and scope. Loi n° 84-12 carries the device definitions and the scope expansion; Loi n° 17-04 supplies the drug-side category that Article 2 pulls into the device regime.

3. Expert insights

Insight 1: Definition first, scope second, with distinct jobs. Article 1 answers what a device is; Article 2 answers what is regulated as a device even if it would not be captured by the definition alone. Article 2 brings into the device regime the products other than medicinal products defined under Article 4 of Loi n° 17-04, devices intended to administer medicinal products, devices incorporating a medicinal substance, and inactive devices manufactured from animal or human tissue. The practical consequence is that certain products which other regulators treat as drugs, or as borderline items drifting between regimes, must go through device registration in Morocco. A company that imports its borderline classification from another market without re-running the Article 2 test is exposed to a wrong-track filing, and a wrong-track filing is usually a rejected filing.

Insight 2: The custom-made device definition carries its own exclusion clause. Item 3 of Article 1 requires that a custom-made device be made under the written prescription of a qualified physician or other person duly authorized by law, for the sole use of a specifically designated patient. The same item expressly excludes products manufactured by continuous or mass production that need only be adjusted by a physician or professional user to fit particular patient requirements. A product manufactured in series and then adapted per patient is not a custom-made device, and the registration exemption in Article 13, item 4 therefore does not apply to it. Teams should treat the exclusion as a mandatory checklist gate: mass-produced plus adjusted equals ordinary registration, and no amount of patient-specific documentation changes that outcome.

Insight 3: Software appears in item 5 of Article 1, but the definition points to programs that run with a device. The text describes software as the set of computer programs necessary for a medical device to operate as intended by its manufacturer. This differs from the European route under the MDR, where software can qualify as a standalone device in its own right; the current Moroccan text leans toward an embedded or accompanying-software reading. Whether standalone software must be registered on its own is a question to resolve against the current AMMPS checklist rather than against imported doctrine, and the answer should be recorded in the project file before any filing decision is made.

Insight 4: The importer definition captures two refurbished categories. Item 9 of Article 1 defines the importing establishment as one engaged in importing new devices, devices refurbished in the country of origin, or used devices that the establishment itself refurbishes before placing them on the market. This leaves a lawful channel for second-hand devices, but the channel is strictly constrained by Article 18 and the ministerial order issued under it, and the constraints must be checked before any refurbishment business case is built.

4. Practical recommendations

1. Run the definition test before any classification discussion. At project initiation, issue a one-page device-qualification memorandum stating the source of intended use (label, instructions for use, promotional material) and the mode of action, and file it as the input to classification.
2. Position drug-adjacent and tissue-derived products early. If the product contains a substance that, used on its own, might be classified as a medicinal product, assess under Article 2 whether its action is ancillary or principal to that of the device, and prepare the corresponding argumentation in the dossier.
3. Do not route mass-produced products through the custom-made exemption. Serial production followed by patient-side adjustment is not a custom-made device and must follow ordinary registration.
4. Preserve intended-use evidence. Item 6 of Article 1 defines intended use by reference to what the manufacturer states on the label, in the instructions for use and in promotional material, so the three sources must be kept consistent with one another.

5. Verification checklist

• □ The product has been confirmed as a medical device within the 17 definitions of Article 1
• □ Whether any of the four Article 2 categories additionally applies has been checked
• □ The principal intended action has been confirmed as non-pharmacological, non-immunological and non-metabolic
• □ For custom-made claims, the exclusion for serial manufacture plus adjustment has been ruled out
• □ The intended-use statements in the label, the instructions for use and the promotional material are consistent
• □ The treatment of accessories and accompanying software has been confirmed
• □ The qualification memorandum has been filed as the classification input

Regulatory information verified as of October 30, 2026. GRZAN supports manufacturers entering the Moroccan market with device qualification, scope analysis under Loi n° 84-12 and Loi n° 17-04, classification, and registration dossier preparation before AMMPS. For project inquiries, contact info@grzanglobal.com.