EU Authorized Representative for Nigeria: From a NAFDAC Power of Attorney to MDR Article 11

NAFDAC classes A to D and the MDR's I to III

The 2024 Regulations set four risk classes:

"(a) class A is low risk; (b) class B is low to moderate risk; (c) class C is moderate to high-risk; (d) class D is high risk" (NAFDAC Regulations 2024, Regulation 3(1))

The First Schedule applies sixteen classification rules with worked examples. Several read closely to the MDR. Under NAFDAC Rule 5, urinary catheters and tracheal tubes for short-term use are class B, and contact lenses for long-term continuous use are class C; under MDR Rule 5 the same devices are typically class IIa and IIb. Under NAFDAC Rule 8, prosthetic heart valves and cardiovascular stents are class D; under the MDR they are class III.

The MDR sets its own frame:

"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 has twenty-two rules. Rules the NAFDAC schedule does not contain, including Rule 11 on software and the rules on nanomaterials and substances introduced into the body, can move a device up a class in Europe. A NAFDAC class is a useful first estimate and nothing more.

Reliance runs into Nigeria only

Regulation 14 of the 2024 Regulations lets NAFDAC use reliance where a device's quality, safety and efficacy have been confirmed, or where the national regulator "is a WHO listed Authority or a harmonised regional economic group with Maturity Level 3 (ML3) competent body" (Regulation 14(1)). The same regulation keeps NAFDAC's "right to its national decision" (Regulation 14(2)).

That mechanism can shorten a CE-marked device's route into Nigeria. There is no counterpart in the MDR. A NAFDAC decision does not shorten conformity assessment, and a Nigerian manufacturer starts in Europe from Annex VIII and the procedures of Articles 52 and 53.

Regulation 4(7) states that registration "shall, unless it is cancelled, be valid for a period of five years and may be renewed."

Power of Attorney and EU authorised representative

NAFDAC's Guidelines for Registration of Imported Medical Devices (R&R-GDL-008-00) require a foreign manufacturer to act through a Nigerian applicant holding a Power of Attorney. The guideline says the document authorises the applicant "to speak for his Principal, on all matters relating to the latter's specialties", must be notarised in the country of manufacture, and must be "Valid for at least five (5) years" (Guideline, Section 3.1.2).

The EU authorised representative is a narrower appointment. It is defined by establishment and a written mandate for specified tasks:

"‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation;" (MDR Article 2(32))

A Nigerian Power of Attorney covering "all matters" is broader than the MDR requires and establishes nothing in Europe. The Article 11 mandate lists what the representative does and what it does not do, and the representative is jointly and severally liable with you under Article 11(5).

Labels written for Lagos and for Europe

NAFDAC labels must "be in English Language and may include any other languages" (Regulation 16(1)(c)) and carry the NAFDAC registration number (Regulation 16(3)(g)). A European label has different fixed content: the CE mark with the notified body number where one is involved, the UDI carrier, and, for a manufacturer established outside the Union, the authorised representative's name and address under Annex I, Section 23.2(d). English covers Ireland and Malta; other Member States set their own language requirements under Article 10(11). Many manufacturers run a separate EU artwork set rather than crowding one label with two regimes.

Getting the Union side in place from Lagos or Abuja

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. Our name and registered address go on the EU label and instructions for use.

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 Kenya, South Africa and Egypt. 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.

We also keep a page for manufacturers in Ghana, where FDA Ghana classifies devices from I to IV on the Canadian model.

Frequently asked questions

Our device is class B with NAFDAC. Is it class IIa under the MDR?

Often, but not automatically. The NAFDAC and MDR examples line up for many devices, such as short-term urinary catheters. The device must still be classified under MDR Annex VIII, which has rules the NAFDAC schedule lacks, and the class decides whether a notified body is needed.

Can our Nigerian Power of Attorney holder act as our EU authorised representative?

No. The MDR requires the authorised representative to be established within the Union; the Commission's 2022 notice extends this to Türkiye under the Customs Union. A company established only in Nigeria cannot accept the mandate.

Will the EU accept our NAFDAC registration?

No. NAFDAC's reliance rules in Regulation 14 decide what NAFDAC accepts from other regulators. The Union does not rely on NAFDAC decisions, and conformity must be demonstrated under the MDR.

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

Federal Republic of Nigeria Official Gazette No. 176 (2024) — NAFDAC Medical Devices and Related Products (Registration, Labelling and Advertisement) Regulations, 2024 — nafdac.gov.ng

NAFDAC — Guidelines for Registration of Imported Medical Devices in Nigeria (R&R-GDL-008-00) — www.nafdac.gov.ng

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

MDCG 2021-24 Rev.1, Guidance on classification of medical devices — health.ec.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.

Other countries we cover

We act as EU authorized representative for manufacturers in many markets. See the pages for Ghana, Kenya, South Africa, Türkiye, the United States and China, or browse the full list by country and the list by device category.

If your devices still need to be registered in EUDAMED, see our EUDAMED registration proposal.