Combination Products: Classification under Article 2 and Article 20

1. Key takeaways

Article 2 of Law No. 84-12 determines what is regulated as a device, and Article 20 determines how combined presentations are regulated. The decision sequence can be stated in three sentences. Where a device and a medicinal product form a single integral product intended exclusively for use in the form presented and not reusable, the product is a medicinal product and follows Law No. 17-04. Where a device contains a substance which, if used separately, might be considered a medicinal product but which acts on the human body in an auxiliary manner to the device, the product remains a device. Where a device is presented in combination with a medicinal product, an in vitro diagnostic reagent or another product, each part remains subject to its own placing-on-market procedure.

These three sentences drive the entire classification of borderline and combination products in Morocco. Getting the sequence wrong at the outset sends the dossier to the wrong authority and the wrong procedure, and every downstream cost, from fees to timeline, follows from that initial call.

The sequence also has an administrative dimension that is easy to overlook. Because the three outcomes point to different laws, they point to different authorities, different application forms, different review periods and different renewal cycles. A product classified as a medicinal product is handled under the marketing authorisation regime of Law No. 17-04; a product classified as a device follows the registration procedure of Law No. 84-12 and Decree No. 2-14-607; a reagent follows Law No. 11-08. Where a presentation contains several components, Article 20 multiplies this effect: each component carries its own procedure, its own fees and its own validity clock. The decision record recommended below is therefore not bureaucratic overhead; it is the document that fixes, for the entire life of the product, which clocks are running and under which law.

2. Legal basis

3. Expert insights

Insight 1: The second item of Article 2 applies a double test of presentation form and non-reusability. The provision states that when a medical device forms a single integral product with a medicinal product, exclusively intended for use in the form in which it is presented and not reusable, the product is a medicinal product within the meaning of Law No. 17-04. Both conditions must be met simultaneously; if either fails, the product is not a medicinal product. Pre-filled syringes and drug-coated stents typically satisfy both conditions and should be assessed on the medicinal product pathway.

Insight 2: The third item draws the line with the notion of auxiliary action. For devices containing a substance which, if used separately, might be considered a medicinal product, the product remains a device where the action of the substance on the human body is ancillary to the action of the device. This preserves a device pathway for drug-eluting products and dressings containing antimicrobial agents, but it requires a demonstration of the auxiliary character of the substance, not a bare assertion. In practice the demonstration should cover the mechanism by which the substance supports the device action, the quantities involved, and the absence of an independent therapeutic effect at those quantities; without these elements, an examiner has no basis on which to accept the auxiliary character.

Insight 3: Article 20 is a procedural separation clause. The provision states expressly that, without prejudice to the application of Article 2, where a device is presented in combination with a medicinal product, an in vitro diagnostic reagent or another product, each relevant product remains subject to its own placing-on-market procedure. A combination pack therefore never means a merged application: where a kit contains both a device and a reagent, two registrations must be obtained.

Insight 4: The first item of Article 2 brings the non-medicinal products of Article 4 of Law No. 17-04 wholesale within scope. This is the connecting point between the two laws and the entry gate for the classification of borderline products (see article 07).

Insight 5: The fourth item leaves a conditional entry gate for devices of tissue origin. Devices manufactured from inactivated animal or human tissues or their inactivated derivatives are regarded as medical devices, provided they satisfy the essential requirements of quality, safety and performance laid down in Article 5. The two conditions are inactivation and compliance with the essential requirements; both must be documented.

4. Practical recommendations

1. Build a combination product decision flowchart. Step one checks the first item of Article 2 (non-medicinal products), step two the second item (integral, non-reusable product, hence medicinal), step three the third item (auxiliary action, hence device), and step four Article 20 (separate procedures). Each step should be recorded with the evidence relied on, so that the conclusion can be defended if the authority questions the classification later.
2. Write the auxiliary action argument as a standalone document. For devices containing a medicinal substance, prepare a specific statement that the action of the contained substance is ancillary, covering mechanism of action and dose-effect relationship.
3. Manage combination packs as multiple certificates. Where a kit contains a device and a reagent, the registration ledger should hold two separate certificates, with renewal reminders set independently.
4. Prepare inactivation proof for tissue-origin products. Under the fourth item of Article 2, provide inactivation process and validation documentation, mapped against the essential requirements of Article 5.

5. Verification checklist

• □ The assessment under the four items of Article 2 has been completed in sequence and the conclusions recorded
• □ The integral product has been assessed against presentation in the form presented and non-reusability
• □ An auxiliary action argument document has been prepared for devices containing medicinal substances
• □ Products presented in combination have been planned under Article 20 with separate procedures
• □ Inactivation proof and essential requirements compliance statements have been prepared for tissue-origin devices
• □ The registration ledger has been established separately for each component of the product
• □ The classification conclusions have been synchronised with the classification and the scope of the dossier

GRZAN support for the Moroccan market. GRZAN supports manufacturers in classifying combination and borderline products for Morocco, preparing auxiliary action arguments, inactivation documentation and Article 20 procedural mapping. For support with registration pathways and classification strategy, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026