EU Authorized Representative for Saudi Arabia: The Same Title, A Different Liability
Saudi Arabia is one of the few export markets where the phrase authorized representative needs no explanation. The SFDA licenses one, per manufacturer, through the GHAD system, and no foreign manufacturer reaches the Saudi market without it. That familiarity is a real head start on MDR, and it is also the trap: the European role carries a liability the Saudi one does not, and the two sets of duties overlap far less than the shared job title suggests.
You already appoint an authorized representative. That is the useful part.
Most manufacturers meeting MDR for the first time have to be talked through why a foreign company needs a resident representative at all. Saudi manufacturers do not. Under the Law of Medical Devices issued by Royal Decree No. M/54 and its Implementing Regulation, an authorized representative in the Kingdom is a legal person holding written authorisation from a manufacturer outside the Kingdom, licensed separately by the SFDA through the GHAD system for each manufacturer it represents (MDS-REQ 9). You have either been one, appointed one, or negotiated with one.
So the concept transfers. The obligations do not, and the mismatch is sharper than it looks, because the two systems use one word for two different legal animals. Below is the comparison that matters before you sign anything.
| Under SFDA rules (MDS-REQ 9) | Under MDR 2017/745 |
|---|---|
| A separate AR licence is obtained for each manufacturer represented | One mandate per manufacturer, effective at least for all devices of the same generic device group (Art. 11(2)) |
| No more than one AR may be appointed for the same class or general group of devices | A sole authorised representative, full stop (Art. 11(1)) |
| The AR’s responsibility does not end when the agreement ends, until a replacement is appointed | The mandate ends when terminated; the outgoing AR must inform the competent authority and the notified body (Art. 11(6)), and Article 12 governs the handover |
| The AR must ensure the manufacturer provides after-sales service, maintenance and approved spare parts | No commercial or service obligation whatsoever. The tasks in Art. 11(3) are documentary, regulatory and vigilance tasks |
| No product-liability provision attaches to the AR | Article 11(5): joint and several liability with the manufacturer for defective devices |
Article 11(5) is the sentence with no Saudi equivalent
Read it in full, because it is the reason EU representation is priced and staffed differently from Saudi representation: "Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer." (MDR Art. 11(5))
Nothing in MDS-REQ 9 does this. The Saudi representative carries duties of cooperation, reporting, continuity and after-sales assurance — real duties, enforced by the SFDA — but it does not stand behind the product in a civil claim brought by an injured patient. The EU representative can. That single difference changes who is willing to hold your mandate, what due diligence they run on your technical documentation before accepting it, and what happens the moment your Article 10 compliance slips. A representative that never looks at your file is not being efficient; it is being negligent about its own exposure.
It also explains Article 11(4): "The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer's obligations laid down in Article 10(1), (2), (3), (4), (6), (7), (9), (10), (11) and (12)." (MDR Art. 11(4)) You cannot buy your way out of the manufacturer’s duties. You can only buy a compliant Union presence to sit alongside them.
The SFDA grants an MDMA. No European authority grants anything.
MDS-REQ 1 is direct about the gate: a device may be made available in the Kingdom only if it is registered at the SFDA and has obtained a Medical Devices Marketing Authorization, and the SFDA grants the MDMA certificate in the name of the manufacturer. There is a named authority, an application, a review and a certificate with an expiry date.
Europe has no equivalent object. There is no EU marketing authorisation for a medical device and no regulator issues one. For class I devices the manufacturer alone draws up technical documentation and signs the EU declaration of conformity under Article 19. Above class I, a private notified body designated under Article 42 issues certificates whose validity "shall not exceed five years" (MDR Art. 56(2)), and even then the declaration of conformity remains the manufacturer’s own document. Saudi teams used to submitting to a regulator and waiting consistently underestimate how much of the European burden is self-generated evidence rather than an application form.
Legal manufacturer: MDS-G11 and MDR Article 16 mean the same thing
The SFDA’s guidance on manufacturing paths sets out three routes — full manufacturing on one Saudi site, manufacturing across the manufacturer’s own sites, and contract manufacturing with independent third parties — and in every one it identifies the entity that places the product under its name and is legally responsible for it as the legal manufacturer whose name goes on the label.
MDR does the same with two provisions. Article 2(30) defines a manufacturer as "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 trademark" (MDR Art. 2(30)). Article 16(1)(a) then catches anyone who "makes available on the market a device under its name, registered trade name or registered trade mark" (MDR Art. 16(1)(a)) and makes them assume the manufacturer’s obligations, unless there is an agreement identifying the actual manufacturer on the label as responsible. If your Riyadh or Sudair plant assembles under a European partner’s brand, that partner is the manufacturer. If you export under your own, you are — and Article 11(1) applies.
Localisation runs inward; the CE mark does not follow it out
The SFDA publishes MDS-G11 explicitly in support of National Strategy for Industry initiatives, including technical and commercial support to device manufacturers and local supply-chain development to enhance localisation. The programme is working: plants that began as importers now design and assemble, and the natural next step is export. The SFDA even issues a free sale certificate for the manufacturer, conditional on holding both the manufacturer licence and the MDMA.
That certificate is evidence for markets that ask for it. The Union does not. There is no reliance route from a Saudi free sale certificate to a CE marking, and an SFDA-accredited conformity assessment body issuing your ISO 13485 certificate is not a notified body under MDR Article 42. Localisation has given Saudi manufacturers a genuine quality system and a documented design history — both of which shorten a European project considerably. Neither replaces the conformity assessment itself.
What the Union side actually involves
Practically: appoint a representative established in a Member State and get the mandate accepted in writing; register as an actor and obtain your single registration number, which the manufacturer must use when applying to a notified body; and put the representative’s name and registered place of business on the label alongside your own, as MDR Annex I, Section 23.2(d) requires. The representative must have a person responsible for regulatory compliance permanently and continuously at its disposal under Article 15(6). Medex holds authorised representative SRN TR-AR-000057550, with an in-house PRRC and a deputy, and offices in Ankara, İstanbul and Gdańsk. Our fees for the representative service are published and class-based, starting at EUR 1000 a year.
Questions from SFDA-licensed manufacturers and their representatives
We hold an MDMA for a class C device. What is that in Europe?
Nothing directly. Saudi classification runs A to D on IMDRF-style rules; MDR runs I, IIa, IIb and III on the twenty-two rules in Annex VIII. The rules resemble each other closely enough that your reasoning is reusable, but the outcome must be re-derived and justified in the technical documentation, because the notified body will test the justification, not the Saudi class.
Our Saudi AR handles everything here. Can they act for us in Europe too?
Only if they have a registered place of business inside the Union — Article 2(32) requires the representative to be established there. A Riyadh entity cannot hold an MDR mandate, however competent, and a European branch office that exists only on paper will not survive a competent authority asking for the documentation in its own official language.
Does our ISO 13485 certificate from an SFDA-accredited CAB count for the MDR audit?
It supports the file and shortens preparation. It does not replace the notified body’s own quality management system assessment under MDR Annex IX, Chapter I. Accreditation by the SFDA and designation as a notified body under MDR Article 42 are separate legal statuses conferred by separate authorities.
The SFDA issued us a free sale certificate for export. Does it help?
It helps in markets that ask for one, and the Union does not. A Saudi free sale certificate confirms that a device holds an MDMA and that the manufacturer is licensed; it says nothing about the general safety and performance requirements in MDR Annex I. Where it does earn its keep is as evidence of a controlled, documented manufacturing operation when a notified body starts asking questions.