EU Authorized Representative for Morocco: From Enregistrement Under Law 84-12 to MDR Article 11

Law 84-12 uses the European class labels

Article 4 of Law 84-12, promulgated by Dahir 1-13-90 of 30 August 2013 and published in Bulletin officiel No 6188, sets four risk classes:

"classe I : risque potentiel faible ; classe II A : risque potentiel modéré ; classe II B : risque potentiel élevé ; classe III : risque potentiel critique." [class I: low potential risk; class IIa: moderate potential risk; class IIb: high potential risk; class III: critical potential risk] (Law 84-12, Article 4)

The criteria listed in the same article, duration of use, invasiveness, surgical use, active or non-active character and contact with vital parts of the body, are those of Annex IX of the former Medical Devices Directive 93/42/EEC. The Union has since replaced that annex:

"Devices shall be divided into classes I, IIa, IIb and III, taking into account the intended purpose of the devices and their inherent risks. Classification shall be carried out in accordance with Annex VIII." (MDR Article 51(1))

Annex VIII of the MDR has twenty-two rules, with new rules for software, nanomaterials, substances absorbed by the body and active devices with a diagnostic function, and several older rules have been tightened. A device that is class IIa in a Moroccan file should be classified again under Annex VIII before the EU route is planned.

Enregistrement authorises the Moroccan market only

Article 12 of the Law makes registration a condition of placing a device on the Moroccan market:

"La mise sur le marché d'un dispositif médical est subordonnée à l'obtention préalable d'un certificat d'enregistrement délivré par l'administration" [Placing a medical device on the market is subject to prior registration, with a certificate issued by the administration] (Law 84-12, Article 12)

The certificate is granted to a manufacturing or importing establishment declared in Morocco under Article 7, and Article 6 of Decree 2-14-607 sets its validity at five years, renewable. Article 15 of the Law requires, before registration, either a clinical investigation or an evaluation of clinical data from the literature where equivalence is demonstrated.

None of this is recognised in the Union. The MDR has no mechanism by which a registration granted by a third country replaces conformity assessment. For class I devices, other than sterile, measuring and reusable surgical instruments, the manufacturer draws up the technical documentation and declares conformity under Article 52(7); above class I, a notified body is involved.

The export free sale certificate

Law 84-12 ties exports to a certificate issued by the Moroccan administration. Its definition of an export establishment covers the export of devices "sous réserve d'obtenir de l'administration un certificat de libre vente attestant que les dispositifs médicaux concernés sont conformes aux règles de bonnes pratiques de fabrication prévues à l'article 11" [subject to obtaining from the administration a free sale certificate attesting that the devices comply with the good manufacturing practice rules under Article 11] (Law 84-12, Article 1(10)).

That certificate is a Moroccan document for Moroccan purposes. EU customs and market surveillance authorities look for CE marking, an EU declaration of conformity, the manufacturer's Single Registration Number in EUDAMED and the name of an authorised representative on the label. A free sale certificate does not stand in for any of them.

Fabricant in Law 84-12 and manufacturer in Article 2(30)

Law 84-12 defines a manufacturing establishment by responsibility for manufacture "au nom dudit établissement" [in the name of that establishment] (Article 1(8)). The MDR also turns on the name under which the device is sold:

"‘manufacturer’ means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade mark;" (MDR Article 2(30))

A Moroccan company that exports under its own brand is the manufacturer for MDR purposes and, because it is not established in a Member State, must designate a sole authorised representative under Article 11(1). A Moroccan plant producing for a European brand owner that puts its own name on the device is a supplier; the brand owner is the manufacturer.

Getting the Union side in place from Casablanca, Rabat or Tangier

Medex Kurumsal Danışmanlık is established in Türkiye. The European Commission's Notice to Stakeholders of March 2022 states that manufacturers established outside the territory of the EU or Turkey "only need to designate one authorised representative, either in the EU or in Turkey, in order to place medical devices on the market in the EU or in Turkey." Switzerland, Great Britain and the EEA-EFTA states require their own local representatives; Medex does not act for those markets.

The steps on our side:

1. Written mandate under Article 11(3). It records the minimum tasks, including verifying that the declaration of conformity and technical documentation exist and keeping copies available to competent authorities.

2. EUDAMED actor registration. Your company registers as manufacturer and receives its Single Registration Number, linked to our authorised representative SRN TR-AR-000057550.

3. UDI. Basic UDI-DI and UDI-DI data are registered for each device before it is placed on the market.

4. Person responsible for regulatory compliance. Medex's PRRC is in-house, as the Regulation requires:

"Authorised representatives shall have permanently and continuously at their disposal at least one person responsible for regulatory compliance who possesses the requisite expertise regarding the regulatory requirements for medical devices in the Union." (MDR Article 15(6))

5. Label and IFU address. Annex I, Section 23.2(d) requires our name and registered address on the label of a device whose manufacturer is established outside the Union. French material prepared for Morocco is a starting point for France and Belgium; each Member State sets its own language requirements under Article 10(11).

Medex works from Ankara, İstanbul and Gdańsk. We do not write technical documentation, we are not a notified body, and we do not find distributors. Annual fees are published on our pricing page, from €800 for class I to €2,000 for class III, with no setup fee and €150 for a change of representative.

Related country and guidance pages

Manufacturers in neighbouring markets face similar questions; we keep separate pages for Tunisia, Egypt and Türkiye. The full list of countries is on the EU authorized representative by country page, and the obligations behind the mandate are set out in our EU authorized representative guide.

Frequently asked questions

Our device is class IIa in Morocco. Is it class IIa under the MDR?

Not necessarily. Law 84-12 uses the same labels, but the classification criteria come from the former Directive. The device must be classified under the twenty-two rules of MDR Annex VIII, which may give a different result.

Does a Moroccan certificat de libre vente help with CE marking?

No. It attests compliance with Moroccan good manufacturing practice for export purposes. CE marking requires the MDR conformity assessment procedures, and the certificate has no standing in that process.

Can our distributor in France act as our authorised representative?

It can accept the mandate if it is established in the Union. It then becomes jointly and severally liable with you under Article 11(5), in addition to its own distributor or importer obligations. Many distributors decline the combined role.

Does a Türkiye-based representative cover the whole EU?

Yes. The Commission's March 2022 notice confirms that manufacturers outside the EU and Turkey need only one authorised representative, either in the EU or in Turkey, to place devices on the market in the EU. Switzerland, Great Britain and the EEA-EFTA states require their own local representatives.

Sources

Ministère de la Santé — Loi n° 84-12 relative aux dispositifs médicaux, Bulletin officiel n° 6188 (19 September 2013) — www.sante.gov.ma

Ministère de la Santé — Décret n° 2-14-607 pris pour l'application de la loi n° 84-12, Bulletin officiel n° 6292 bis (19 September 2014) — www.sante.gov.ma

Council Directive 93/42/EEC concerning medical devices, consolidated text of 11.10.2007 (Annex IX) — eur-lex.europa.eu

Regulation (EU) 2017/745 on medical devices, consolidated text — eur-lex.europa.eu

European Commission — Notice to Stakeholders: EU-Turkey Customs Union Agreement in the field of medical devices (March 2022) — health.ec.europa.eu

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Related guides

Before you appoint anyone, our EU authorized representative guide explains the role and what a mandate covers, the EU authorized representative cost guide shows what the fee should include, and the buyer's checklist helps you compare providers. The contract itself is covered in our note on the mandate agreement under Article 11(3). When you are ready, you can request a proposal.