EU Authorized Representative for Kenya: From a PPB Registration and Local Authorized Representative to MDR Article 11
Kenya registers medical devices through the Pharmacy and Poisons Board, which classifies them from A to D and offers abridged and expedited routes for devices already approved by its reference regulators, the European Union among them. That reliance works for devices coming into Kenya. It does not work in the other direction. A Kenyan manufacturer selling in Europe under its own name needs CE marking under Regulation (EU) 2017/745 and a sole authorised representative established in the Union or in Türkiye.
PPB classifies devices from A to D
The Pharmacy and Poisons Board's Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics (document PPB/PER/MDV/GDL/005) set four risk classes. The guideline's own examples give a sense of the scale: class A, "Low Risk", includes "Cotton wool, bandages, urine collection bottles; compression hosiery; non-invasive electrodes, hospital beds"; class D, "High Risk", includes "Pacemakers; Implantable defibrillators" and "prosthetic heart valves; cardiovascular stents" (PPB Guidelines, Part 2, Table 1).
The MDR uses different labels:
"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))
The two systems often land in corresponding places. Urinary catheters and tracheal tubes, class B in the PPB table, are typically class IIa under Rule 5 of the MDR for short-term use; long-term contact lenses, class C in the PPB table, are class IIb under the same rule. The correspondence is not a rule. Annex VIII contains twenty-two rules and its own implementing provisions, and a Kenyan class should be treated as a starting point, not an answer.
Reliance on the EU runs into Kenya only
The PPB guideline sets abridged, expedited and immediate routes for devices already approved elsewhere. It lists the European Union among the approvals it recognises, and for the abridged route states:
"A medical device that has obtained at least three reference regulatory agency approval for a labelled use identical to that intended for marketing in Kenya at the time of submission will qualify for the abridged evaluation route." (PPB Guidelines, Section 2.5.1)
CE marking therefore shortens the path into Kenya. The Union has no reciprocal list. A PPB registration does not shorten or replace conformity assessment under the MDR, and a Kenyan manufacturer entering Europe starts from Annex VIII and the procedures of Articles 52 and 53.
| Kenyan instrument | What it does in Kenya | Effect in the EU |
|---|---|---|
| PPB certificate of registration | Authorises marketing in Kenya; valid for five years | None |
| Local Authorized Representative | Exclusive local appointment for registration, import and sale | None; it cannot act as EU authorised representative |
| Reference-agency reliance routes | Shorten the Kenyan review for devices approved elsewhere | Not applicable; the EU does not rely on PPB decisions |
| PPB good manufacturing practice inspection | Confirms manufacturing practice for Kenyan registration | None; the notified body audits the quality management system itself |
The guideline states that "The certificate of registration is valid for 5 years." (PPB Guidelines, Section 2.12).
Local Authorized Representative and EU authorised representative
Kenya requires a Local Authorized Representative for manufacturers located outside the country, and the guideline gives that appointment a commercial scope:
"The Local Authorized Representative Must obtain a letter from the Manufacturer appointing them as the Exclusive LAR, With the exclusive rights for distribution, sale, importation and registration of the medical device." (PPB Guidelines, Section III(c))
The EU authorised representative is a regulatory appointment, not a commercial one. It is defined by establishment and by a written mandate:
"‘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))
Nothing in the MDR gives the authorised representative distribution or sales rights, and the mandate does not have to include them. A Kenyan manufacturer that keeps its commercial partners separate from its regulatory representative in Europe keeps the freedom to change distributors without changing its EUDAMED registration.
Getting the Union side in place from Nairobi or Mombasa
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. English material prepared for Kenya covers Ireland and Malta; the other Member States set their 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 South Africa, Egypt and Tunisia. 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 Nigeria, covering NAFDAC classes A to D and the Power of Attorney route.
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 the PPB. Is it class IIa under the MDR?
Often, but not automatically. The PPB and MDR examples line up in many cases, such as short-term urinary catheters. The device must still be classified under MDR Annex VIII, and the class decides whether a notified body is needed.
Kenya accepts CE marking for abridged review. Will the EU accept a PPB registration?
No. The reliance routes in the PPB guideline are Kenyan import rules. The Union does not rely on PPB decisions, and conformity must be demonstrated under the MDR.
Can our European distributor be 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). Many distributors decline the combined role, and it makes a later change of distributor harder.
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
Pharmacy and Poisons Board — Guidelines for Registration of Medical Devices Including In-Vitro Diagnostics — web.pharmacyboardkenya.org
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 South Africa, Türkiye, Israel, Saudi Arabia, 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.