Custom-Made Devices and Exhibition Samples: Definitions and Boundaries

1. Key takeaways

Custom-made devices and exhibition samples both appear in the registration-exemption list of Article 13, but the boundaries of the two are entirely different: custom-made devices turn on definition (Article 1, item 3), while exhibition samples turn on setting (Article 13, item 6). The definition of custom-made devices excludes products manufactured in series or in batches and merely adapted by a physician or professional user to meet the specific needs of a patient. Exhibition samples, for their part, must be accompanied by clearly visible signage stating that the device may not be placed on the market or put into use before registration is completed. Both categories still require a specific authorisation.

The practical consequence is that the two routes demand different evidence from the outset: the custom-made route is defended through prescriptions and one-off manufacture records, while the exhibition route is defended through signage, custody records and the demonstrable absence of any sale. Confusing the two boundaries is one of the most frequent causes of enforcement exposure.

The two routes also fail in different ways. A custom-made file fails at classification: if the manufacture is in reality continuous or batch production, the whole route collapses and the activity becomes an unregistered placing on the market, with the penalty tiers of Article 44 attached. An exhibition file fails at conduct: the classification may be perfectly correct, but a missing signboard, a sample handed to a visitor, or a device quietly left with a distributor converts a lawful display into the marketing of samples, which Article 44 likewise sanctions as a percentage of turnover. Preparing for the two routes therefore means preparing for two different audits: one of the production model and prescriptions, the other of the booth, the signage and the movement of every sample on site.

2. Legal basis

3. Expert insights

Insight 1: The definition of custom-made devices carries its own exclusion clause, which is the most common failure point. After setting out the definition, Article 1, item 3, immediately provides that devices manufactured by means of continuous or batch production and merely requiring adjustment by a physician or professional user to meet the specific needs of a patient are not regarded as custom-made. This excludes the great majority of industrially manufactured configurable products, such as orthoses adjusted to patient size or dressings cut to shape. A company that files under the custom-made route and is found to be producing in batches will be treated as placing unregistered devices on the market.

Insight 2: Custom-made devices require the twin conditions of a written prescription and a specific patient. The definition requires a written prescription issued by a qualified physician or a person lawfully authorised, and the device must be intended for the exclusive use of a specific patient. Neither condition can be omitted: a so-called custom-made device without a written prescription is not custom-made at all, whatever the manufacturing method.

Insight 3: For exhibition samples, compliance centres on the single act of display. Article 13, item 6, covers samples imported or locally manufactured for display to professionals at exhibitions, scientific congresses and fairs. The key point is that the display must be accompanied by clearly visible signage. The provision formulates the signage requirement as mandatory language, not as guidance, and inspectors can verify it on the spot.

Insight 4: Article 44 places the unauthorised marketing of both kinds of samples among the heavily sanctioned offences. The provision expressly lists the placing on the market of samples imported for evaluation, as well as samples imported or locally manufactured for display, among the infringements sanctioned as a percentage of turnover. The distinction between a sample and commercial goods is in Morocco a question of law, not a matter of commercial judgement.

Insight 5: The applicant for a specific authorisation remains subject to the site logic of Article 12. Although Article 13 exempts these devices from registration, the application for a specific authorisation must still be submitted by a duly qualified Moroccan site, as reflected in the procedures of Annex I of Ministerial Order No. 2855-15. In practical terms, this means the Moroccan partner, whether importer or declared production site, must be involved from the start of a custom-made or exhibition project, since it is the site, not the foreign manufacturer, that faces the authority.

4. Practical recommendations

1. Screen custom-made candidates against batch production first. If the product is manufactured through continuous or batch processes, do not use the custom-made route; plan conventional registration directly.
2. Retain written prescriptions case by case. Build a prescription file for each custom-made device, recording the patient correspondence and the basis of manufacture.
3. Standardise exhibition signage. Produce the signage in French and Arabic, stating that the device may not be placed on the market or put into use before registration is completed.
4. Cover the full lifecycle of samples in the ledger. From customs import and booth custody through demonstration records to return or destruction, form a closed loop of evidence.
5. Prohibit on-site sales after exhibitions. Internal procedures should define only two exits for samples, return or conversion to registration, and explicitly forbid a third. A standard operating procedure signed before the exhibition, naming the person responsible for each sample and the decision point after the event, is more effective than any after-the-fact explanation.

5. Verification checklist

• □ Custom-made devices have been confirmed as outside the batch production with patient-side adjustment exclusion
• □ Written physician prescriptions indicating the specific patient have been obtained case by case
• □ A specific authorisation under Article 13 has been applied for exhibition samples
• □ Clearly visible compliant signage has been installed at the booth (French and Arabic recommended)
• □ An import, custody, demonstration and disposal ledger has been established
• □ Internal procedures prohibit the on-site sale of samples
• □ The penalty risk under Article 44 for marketing samples has been assessed

GRZAN support for the Moroccan market. GRZAN helps manufacturers distinguish custom-made devices from configurable batch-produced products, prepare specific authorisation files under Ministerial Order No. 2855-15, and set up exhibition sample procedures for Morocco. For support with registration pathways and classification strategy, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026