Tiered Clinical Data Submission for Medical Devices in Morocco

1. Key takeaways

Article 15 of Law No. 84-12 requires, at the level of the statute, that all devices undergo a clinical investigation or an evaluation of clinical data based on equivalence before certification is granted. The current AMMPS registration checklist, however, states that a complete technical dossier is not required for imported devices, and that clinical data is mainly required for Class III. The relationship between the two is this: the statute gives the principle, the checklist gives the depth of execution. Low and medium-risk products follow the literature-based equivalence route, while Class III devices prepare complete clinical documentation.

Reading both sources is therefore mandatory, not optional. A team that reads only the statute will over-prepare clinical evidence for every class; a team that reads only the checklist will have no answer when a reviewer asks for the legal basis of a thinner file. The dossier should cite both the article and the checklist, which preserves room to respond whichever direction a question comes from.

Clinical evaluation in Morocco is also a continuing obligation. Article 16 requires the certificate holder to keep evaluating clinical data and to notify changes affecting that data or the registration dossier in writing. Article 15 is a one-time threshold and Article 16 is a long-term duty; together they form the closed loop of clinical compliance in Morocco.

2. Legal basis

Practical estimate: the position that no complete technical dossier is required for imported devices and that clinical data is limited to Class III comes from the public position of the current AMMPS checklist and is a practical estimate. The Article 15 requirement at the level of the statute applies to all classes. Where the two diverge, the current requirement of the competent authority prevails.

3. Expert insights

Insight one: the gap between the statute and the checklist is not a contradiction but a result of delegated legislation. The first paragraph of Article 15 states the principle for certification, the second paragraph states the objectives of the evaluation, and the third paragraph requires the results to be entered in the dossier. The checklist builds on this base to fix the depth of submission by class. Reading the statute alone leads to over-preparation; reading the checklist alone leaves the team without grounds when challenged. Both documents must be read, and both should be cited in the dossier.

Insight two: the equivalence route is the realistic choice for Class IIA and IIB. Article 15, first paragraph, item 2 permits clinical data to be evaluated through scientific literature where the applicant demonstrates a proven equivalence between the device under application and the device to which the data relates. For products with mature comparator devices, this is the lowest-cost route, but it demands rigorous equivalence argumentation. The argument must stand on its own, because a reviewer who doubts equivalence returns the entire clinical section for rework.

Insight three: the complete clinical documentation for Class III should be understood as material that independently supports the benefit-risk conclusion. Article 15, second paragraph, lists three objectives of evaluation: performance under normal conditions of use, the comparison of benefit and risk together with the determination of undesirable side-effects, and confirmation of conformity with the essential requirements of Article 5. Class III clinical documentation should support these three objectives independently, rather than citing the conclusions of others. A Class III file assembled from borrowed conclusions is the weakest possible version of a strong obligation.

Insight four: a local clinical investigation crosses into another statute. Where a clinical investigation is conducted within Morocco, Article 15, first paragraph, item 1 requires it to be carried out in accordance with the laws and regulations in force, which brings the subject protection provisions of Law No. 28-13 on biomedical research into play. GRZAN recommends preferring existing foreign clinical data and literature, and considering a local investigation only where necessary, since a local study adds a second regulatory track with its own approvals and timelines.

Insight five: clinical evaluation is a continuing obligation. Article 16 requires the certificate holder to evaluate clinical data continuously and to notify in writing any change affecting that data or the content of the registration dossier. Article 15 is a one-time threshold and Article 16 is the long-term duty; the two together form the closed loop of clinical compliance in Morocco. A project that plans only for the threshold leaves the maintenance obligation unstaffed.

4. Practical recommendations

1. Fix the depth of clinical documentation by class. Follow the literature-based equivalence route for Class IIA and IIB, and prepare complete clinical documentation for Class III, avoiding a one-size-fits-all approach in either direction.
2. Make the equivalence argument a stand-alone document. Compare technical, biological, and clinical characteristics item by item, and attach the literature sources for the comparator device, so the argument can be reviewed without hunting through the technical file.
3. Prefer existing foreign data. Avoid launching local clinical investigations unless the competent authority explicitly requires one, given the added track under Law No. 28-13.
4. Bring Article 16 into annual maintenance. Set an annual clinical data review milestone and notify changes in writing when they occur, so the continuing obligation has a calendar rather than depending on memory.
5. Cite both the statute and the checklist as grounds. Reference Article 15 together with the current checklist in the dossier, preserving room to respond if the depth of documentation is questioned from either direction.

5. Verification checklist

• □ Depth of clinical documentation fixed according to device class
• □ Equivalence argumentation written up with literature sources for low and medium-risk products
• □ Class III clinical documentation independently supports the three evaluation objectives of Article 15, second paragraph
• □ Need for a local clinical investigation and the requirements of Law No. 28-13 assessed
• □ Annual review milestone under Article 16 established
• □ Dossier cites both Article 15 and the current checklist as grounds
• □ Results of clinical evaluation entered in the registration dossier under Article 14

GRZAN supports manufacturers with tiered clinical evidence strategies for medical device registration in Morocco, including equivalence argumentation against Article 15, Class III clinical documentation planning, Law No. 28-13 assessments for local investigations, and Article 16 maintenance calendars. For assistance with registration documentation and conformity files for Morocco, contact GRZAN at info@grzanglobal.com.

Regulatory information verified as of 30 October 2026