Our name goes on the label only after your file stands up to review.
A manufacturer established in Saudi Arabia is outside the European Union for MDR and IVDR purposes. MEDDEV reviews the available home-market evidence, defines the EU file and accepts the Article 11 mandate only when the documentation and liability criteria are met.
For Saudi medical-device and IVD manufacturers preparing EU market entry, transferring an existing mandate or coordinating EUDAMED responsibilities.
Online intake Secure connection 
Saudi manufacturers arrive with a marketing authorization built under the Medical Devices Law: registration with the SFDA through the GHAD system and a Medical Device Marketing Authorization for the authorized device grouping. Since the beginning of 2021 the SFDA no longer accepts applications based on approvals from other jurisdictions, so an MDMA applied for after that date is supported by the manufacturer’s own technical documentation against the Essential Principles of safety and performance. That is a real starting position for the EU route — the work is mapping the dossier to MDR or IVDR, not writing one from zero.
Under SFDA requirements a medical device may be made available in the KSA only if it is registered at the SFDA and a Medical Device Marketing Authorization has been obtained, with applications submitted through the GHAD system. The MDMA evidences Saudi market status. The EU requires its own conformity assessment under MDR or IVDR, with obligations placed on the legal manufacturer.
The SFDA announced that 1 January 2021 was the last day for accepting marketing-authorization applications via the GHTF route, which had relied on approvals from founding GHTF jurisdictions. An MDMA applied for after that closure therefore rests on the manufacturer’s own technical documentation: an Essential Principles checklist, a risk management file and clinical or performance evidence. An authorization that still traces back to a pre-2021 GHTF application is a different starting point, which is why we ask about the original basis. Where the file is the manufacturer’s own, much of its substance can be reused for the EU route — the structure and the legal tests are what change.
The SFDA classifies medical devices as Class A, B, C and D, with sub-categories for sterile Class A devices, those with a measuring function and reusable surgical instruments, under twenty-two classification rules for devices other than IVDs; in vitro diagnostics have their own, separate set of classification rules. The vocabulary is close to the EU’s, and the SFDA describes its annexes as harmonized with international regulatory requirements, but the EU classification is argued from the MDR or IVDR rules and the intended purpose as it will be worded for the Union market — not read across from the Saudi class.
Official basis: SFDA MDS-REQ 1: requirements for medical devices marketing authorization, SFDA: closure of the GHTF marketing-authorization route, European Commission: authorised representatives, MDR Article 11, European Commission: EUDAMED UDI/Device registration.
For Saudi manufacturers, SFDA records and local-market documentation may support the assessment, while the EU route remains separate. The mandate review focuses on the legal manufacturer, intended purpose, product-liability arrangements and the evidence needed for European importers and authorities.
Need the wider comparison? Compare home-market evidence with the EU MDR/IVDR route →
The initial website form contains no document upload. After the parties and scope are confirmed, MEDDEV provides a controlled transfer route for the records below.
SFDA establishment registration and licence details from the GHAD system, and the legal-manufacturer identity for the proposed EU portfolio.
MDMA certificates with their authorized scope and grouping, plus the application route and date — an authorization issued via the pre-2021 GHTF route may rest on another jurisdiction’s approval rather than on a full in-house file.
The technical documentation behind the MDMA: Essential Principles checklist, risk management file, clinical or performance evidence and the quality-system certificate to SFDA.MD/GSO ISO 13485 or its equivalent.
Intended purpose as it will be worded for the EU market, with the MDR or IVDR classification rationale built from the Union rules.
Saudi manufacturers know the authorized-representative institution from their own system: a foreign manufacturer selling into the KSA appoints an SFDA-licensed representative resident in the Kingdom, licensed separately for each manufacturer it represents. The EU role under Article 11 of the MDR and IVDR is the mirror image — same words, different law. An SFDA licence carries no weight in the Union, and the EU mandate, vigilance duties and EUDAMED responsibilities have to be established on EU terms.
The records behind an MDMA can reduce duplicated work, subject to their completeness and their conformity with MDR or IVDR requirements. The authorization itself does not demonstrate conformity with the general safety and performance requirements and does not replace conformity assessment, CE marking, the EU declaration of conformity or, where required, notified-body involvement.
Treating a Class B device as “the same as” a particular MDR class skips the step that determines the conformity route, the evidence expected and whether a notified body is involved. The EU class is derived from the Union rules each time.
Four modules — actor registration, UDI/Devices, notified bodies and certificates, and market surveillance — have been mandatory since 28 May 2026 under Commission Decision (EU) 2025/2371 and Regulation (EU) 2024/1860. For devices placed on the market earlier and still being placed on the market, Regulation (EU) 2024/1860 allows no later than twelve months from publication of the Commission notice, which was published on 27 November 2025. Registration data therefore belongs in the market-entry plan, not after it.
MDR Article 10(16) — mirrored for in vitro diagnostics by IVDR Article 10(15) — requires manufacturers to have measures in place providing sufficient financial coverage for potential liability under Directive 85/374/EEC, in a manner proportionate to the risk class, type of device and size of the enterprise. It does not prescribe a particular insurance policy. MEDDEV asks to see those measures because Article 11(5) makes the authorised representative legally liable for defective devices on the same basis as, and jointly and severally with, a manufacturer that has not met its Article 10 obligations. Reviewing the arrangement is our acceptance condition, and that provision is why.
Establish, per authorization, when it was issued and on what documentation — an own-file MDMA and a pre-2021 reliance MDMA set up very different EU projects.
Set the MDR or IVDR classification and conformity route independently, then record which parts of the Saudi technical file meet the EU requirements and which items remain open.
Complete the technical file review, agree the registration data and coordinate the mandate, labelling and EUDAMED work against the confirmed entity and scope.
It helps as evidence, not as a route. An MDMA applied for after the GHTF route closed in 2021 is supported by the manufacturer’s own technical documentation against the SFDA’s Essential Principles, and much of that substance — risk file, bench and clinical or performance evidence, quality-system records — can be reused where it meets MDR or IVDR requirements. The authorization itself is a Saudi decision and does not transfer.
It is the same idea pointing the other way, under different law. In the Saudi system the AR is licensed by the SFDA, resident in the Kingdom and licensed per manufacturer. In the EU the authorised representative is designated under Article 11 of the MDR or IVDR, with statutory duties and liability conditions defined by the Regulation. Neither appointment substitutes for the other.
No. The systems use similar language and similar risk logic, but the rules differ and the EU class follows from the MDR or IVDR classification rules applied to the intended purpose as worded for the Union market. The class determines the conformity route, so it is re-derived rather than translated.
Article 11(1) of the MDR and IVDR states that where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative. MDCG 2022-16 explains what “sole” means in practice: across a portfolio a manufacturer can have more than one authorised representative where the devices fall under different generic device groups, but for any one generic device group only one. It is a condition of placing the device on the market, not a formality afterwards.
MEDDEV reviews the legal manufacturer, device identity, classification, conformity route, technical-documentation index, insurance, vigilance arrangements and sanctions screening.
No. The form is for qualification only. A controlled document-transfer route is provided after scope and parties are confirmed.
MEDDEV accepts only defined device scopes supported by evidence, working safety controls and a manufacturer we can rely on. A commercial enquiry never guarantees appointment. Our name appears on the label only after the acceptance review is complete.
Accepted manufacturers may use the mark where professional buyers assess regulatory readiness. Each use must remain connected to the active MEDDEV mandate and its defined device scope.
Use boundary: the mark must not appear as a CE mark, product certificate or safety approval. It should not be added to the regulated device label, instructions for use or sterile-packaging information panel.
We do not publish a one-size-fits-all price because the mandate depends on the device, portfolio and level of responsibility. The initial review identifies the scope before a fee is proposed.
Classification, IVD or medical device route, number of families, intended purpose and higher-risk features.
Technical documentation, clinical or performance evidence, quality-system records, certificates and labelling.
EUDAMED coordination, vigilance, authority response, importer interface, PRRC support and required review depth.
Fee principle: after the qualification review, we provide a defined scope and a proposal matched to the accepted mandate. No document upload is required in the first contact form.
Confirm the entity, country of establishment, device family and intended EU market.
Have the classification rationale, technical-file index, conformity route and quality evidence available.
Identify complaint, vigilance, field-safety and authority-response owners before the mandate begins.
These anonymised composite scenarios reflect recurring qualification patterns. They are not attributed client case studies or performance claims; the exact scope and outcome depend on the manufacturer and device file.
Problem: home-market approval is mistaken for EU access. Work: map MDR/IVDR, labelling, EUDAMED and importer responsibilities. Typical result: a defined launch route and a documented list of open evidence.
Problem: the outgoing representative controls records and dates are unclear. Work: plan custody, vigilance ownership and handover steps. Typical result: a controlled transition with responsibilities recorded before the new mandate starts.
Problem: a Class IIb, Class III or complex IVD portfolio has unresolved evidence or liability gaps. Work: enhanced file and response-readiness review. Typical result: accept, request defined evidence, or decline before exposure is created.
Each briefing states the provision it relies on and links to the official text. They are written for companies deciding whether, and in what order, to enter the European market.
Four modules became mandatory on 28 May 2026. The twelve-month obligation does not cover every device, and the wording decides which.
Read the EUDAMED briefing →Products covered by the MDR are excluded. Companion software without a medical purpose, portals and service tools are not.
Read the cybersecurity briefing →The notice goes to the authority of the Member State where the manufacturer or its authorised representative is established.
Read the supply briefing →What transfers into a European file, what has no equivalent at home, and where a representative is required by law.
Open the compliance hub →Priority goes to complete, traceable applications with a named regulatory owner. Meeting the entry criteria qualifies a scope for a decision; it does not guarantee acceptance.
The legal entity, authorised signatory, manufacturing sites, device families, models and intended purposes are consistent and traceable.
The qualification, classification and conformity-assessment route are documented, with valid notified-body involvement where required.
The EU declaration, agreed technical-documentation index, certificates, labelling and registration data describe the same device scope.
Risk management, surveillance, complaints, vigilance, recalls and corrective actions have current records, owners and escalation routes.
Named decision-makers can provide records, samples and technical answers and can act within agreed authority-response times.
Insurance, contractual responsibility, document access, sanctions screening, change notification and mandate continuity are acceptable.
What the status means: “MEDDEV Mandate Accepted” confirms MEDDEV’s written acceptance of an EC REP mandate for the defined device scope. It is a trust signal about regulatory readiness and the manufacturer relationship. It is not a CE certificate, product approval, independent safety claim or substitute for the applicable conformity assessment.
Mikołaj Junosza-Szaniawski leads mandate governance, risk oversight and international delivery. Marta Junosza-Szaniawska and Barbara Jęcka-Izdebska remain the named specialists for conformity assessment, registration and ongoing regulatory coordination.
Mikołaj brings more than 25 years of experience at KPMG, including as a Director in Audit Assurance, where he oversaw major sustainability-reporting assurance projects. He combines international project governance with a product-life-cycle perspective encompassing LCA, reuse, recyclability and environmental performance. At MEDDEV, he oversees mandate governance, risk escalation, specialist assignment and continuity of manufacturer communication.
The manufacturer does not need to coordinate a loose group of advisers. The named coordinators define the review scope, assign the relevant specialists and remain accountable for communication and the agreed regulatory work.
Marta coordinates the initial regulatory assessment, defines the file-review scope and confirms whether MEDDEV can accept the representative mandate.
marta.szaniawska@meddev.pl +48 791 480 270
Barbara coordinates registration and notification work and remains a named contact for the practical steps that follow appointment.
barbara.jecka@meddev.pl +48 730 354 190