Our name goes on the label only after your file stands up to review.
A manufacturer established in Japan 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 Japanese medical-device and IVD manufacturers preparing EU market entry, transferring an existing mandate or coordinating EUDAMED responsibilities.
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Japan authorises market access through a licensed Marketing Authorization Holder; the EU places its obligations on the legal manufacturer, defined in Article 2(30) of the MDR as the entity that manufactures — or has a device designed or manufactured — and markets it under its own name or trademark. Those two roles sometimes sit in the same company and sometimes do not. MEDDEV does not decide who the EU manufacturer is; we establish the actual structure and test it against that definition, because everything downstream inherits the answer.
PMDA describes notification to PMDA for Class I, certification by a registered certification body for Class II and Class III where certification standards exist, and approval of the MHLW for the remainder and for Class IV. Formal approval is issued by the MHLW; PMDA undertakes the product review. Each is a Japanese authorisation. None of them is, or substitutes for, the conformity assessment procedure required under MDR or IVDR.
The decision does not carry over, but much of what supports it can. Bench testing, biocompatibility and validation data, clinical or performance evidence and quality-system records can be reused where they meet the MDR or IVDR requirements. What has to be rebuilt is the argument: classification from the Union rules, a technical documentation structure the Regulations recognise and a declaration signed by the right entity.
Japan and the EU both use risk classes and similar vocabulary, but the classification rules differ and an IVD is not classified on the same scale as a device. A device does not carry its Japanese class into the Union. Classification is argued from the MDR or IVDR rules and from the intended purpose as it will be worded for the EU market.
Official basis: PMDA: review of medical devices, European Commission: authorised representatives, MDR Article 11, European Commission: EUDAMED UDI/Device registration.
Japanese manufacturers commonly need a clear bridge between PMDA or MHLW records and the European technical file. The review focuses on intended purpose, classification, clinical or performance evidence, labelling and the exact device families proposed for EUDAMED.
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.
The actual entity structure: who manufactures, who has the device designed or manufactured, whose name or trademark appears on it, and how the Japanese MAH relates to each.
Domestic status per device family — notification, certification by a registered certification body, or MHLW approval — with the documents actually issued.
Intended purpose as it will be worded for the EU market, with the MDR or IVDR classification rationale built from the Union rules.
Technical documentation index, quality-system evidence, clinical or performance evidence, and the Basic UDI-DI and UDI-DI structure planned for the Union portfolio.
An MHLW approval or a registered certification body certificate evidences Japanese market status and can materially shorten a review. It does not demonstrate conformity with the general safety and performance requirements, and it does not replace the EU conformity assessment procedure.
Under Article 2(30) the EU manufacturer is determined by what a company actually does and whose name is on the device — not by preference or convenience. Where a group has a Japanese MAH, an overseas parent and a manufacturing subsidiary, the relationship has to be documented and the EU document set has to be internally consistent. Japanese records may correctly name the MAH; that is not a defect to be edited away.
Wording written for a Japanese submission often does not survive translation into an MDR intended purpose. Broadening it for the EU market may change the classification, the evidence expected and the conformity route.
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.
Document who manufactures, who markets under whose name, and how the Japanese MAH fits — then test that against the Article 2(30) definition rather than assuming an answer.
Record what the Japanese notification, certification or approval actually covers, then set the MDR or IVDR classification and route independently, while identifying which underlying evidence can be reused.
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. PMDA states that approval is issued by the MHLW following PMDA product review — a domestic authorisation. The EU requires its own conformity assessment against MDR or IVDR. The supporting data behind the Japanese decision can often be reused; the decision itself cannot.
It can, if it meets the Article 2(30) definition — if it manufactures, or has the device designed or manufactured, and markets it under its own name or trademark. Sometimes the MAH and the EU manufacturer are the same company and sometimes they are not. It is a question of fact about your structure, not a matter of choosing the more convenient entity.
No. A registered certification body certifies designated devices against Japanese certification standards within the Japanese system. A notified body is designated under MDR or IVDR by an EU Member State. The two are separate systems and the certificates are not interchangeable.
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