ARTG and WAND are local systems
Australian ARTG inclusion and New Zealand WAND notification do not create an EU EC REP mandate or EUDAMED registration. WAND is a notification system, not an approval system.
Sell medical devices in the EU from Australia or New Zealand · MDR / IVDR Article 11 
EU Authorized Representative for Australian and New Zealand manufacturers.
Our name goes on the label only after your file stands up to review.
ARTG inclusion or a New Zealand WAND notification records home-market status. MEDDEV reviews the available evidence against MDR or IVDR, defines the EU mandate and coordinates the EUDAMED responsibilities that follow.
For Australian and New Zealand medical-device and IVD manufacturers building a controlled path into the European Union.
Established in the European UnionWarsaw, Poland · EC REP under MDR and IVDR Article 11
Online intake Secure connection MEDDEV brand serving medical-device companies since 2012 MDR 2017/745 & IVDR 2017/746 Mandate accepted only after review
Manufacturers who have worked with MEDDEV
Australia and New Zealand → European Union
Home-market records inform the review. They do not replace EU conformity.
TGA and Medsafe operate their own market systems. MEDDEV uses the existing dossier as an evidence base, then makes the EU-specific gaps, owners and appointment criteria visible.
Preserve useful evidence
Risk, quality, clinical, performance and post-market records are mapped rather than discarded, with EU-specific differences recorded.
Work across time zones in writing
Review scope, open items and decisions are documented so the manufacturer has a durable record between scheduled calls.
Official basis: TGA: medical devices, Medsafe: WAND is not an approval system, MDR Article 11, European Commission: EUDAMED UDI/Device registration.
Local review focus
What usually needs attention for Australia & New Zealand manufacturers.
For Australia and New Zealand, ARTG and WAND records are useful starting points but represent different home-market systems. The EU review therefore separates the two jurisdictions, confirms the legal manufacturer and creates one controlled MDR or IVDR portfolio before the mandate is accepted.
Need the wider comparison? Compare home-market evidence with the EU MDR/IVDR route →
Qualification file
What to prepare for the first EU review.
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.
- 01
Australian ARTG inclusion records or New Zealand WAND notifications for the proposed EU device scope.
- 02
Legal-manufacturer, sponsor, manufacturing-site and device-family list with current home-market labels.
- 03
ISO 13485 and conformity-assessment evidence together with the proposed MDR or IVDR classification and EU route.
- 04
Technical-documentation index, clinical or performance evidence, PMS records and product-liability policy.
Typical transition gaps
Issues to resolve before the mandate starts.
Notification is not EU conformity
A WAND notification is not a Medsafe approval, and neither WAND nor ARTG creates an MDR or IVDR mandate.
Different product groupings
Home-market sponsor records and device families may need restructuring for EU declarations, Basic UDI-DI and EUDAMED.
Remote file availability
The EC REP needs durable access to controlled records and named vigilance contacts despite the time-zone difference.
EUDAMED is no longer a future obligation
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.
Financial coverage: what the law says, and what we ask for
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.
Country-specific route
01 02 03
Check this portfolio →
From home-market records to EU representation.
Select the correct home country
The combined guide does not preselect Australia or New Zealand; the manufacturer confirms its establishment in the intake.
Map ARTG or WAND records
Connect home-market products, sponsors, evidence and sites to the proposed EU device scope.
Create the EU control layer
Close MDR or IVDR gaps, accept the mandate, release EC REP labelling and coordinate EUDAMED.
Questions from Australia & New Zealand
What manufacturers ask before appointment.
Is a WAND notification a medical-device approval?
No. Medsafe states that WAND is a notification system and does not mean that the device has been assessed for quality, safety, efficacy or performance.
Does ARTG inclusion remove the need for an EC REP?
No. An Australian-established manufacturer without an EU place of business still needs the separate Union-market route.
Why is no country preselected in the form?
This guide serves two jurisdictions. The manufacturer must deliberately select Australia or New Zealand so the enquiry is recorded correctly.
Can the review be handled across time zones?
Yes. MEDDEV records scope, gaps, owners and decisions in writing and schedules live discussions for matters that require them.
Acceptance is earned, not purchased
Not every mandate is accepted.
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.
MEDDEV mandate reviewAcceptance gate
Manufacturer, device and intended purposeAcceptance criterion
Conformity route and regulatory evidenceAcceptance criterion
Safety, post-market and vigilance controlsAcceptance criterion
Communication, response and liability arrangementsAcceptance criterion
Outcome: mandate accepted, conditions issued or mandate declined.
A status worth displaying
Turn regulatory acceptance into a visible trust signal.
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.
- Manufacturer websiteAlongside EU market-access information and the represented device portfolio.
- Product catalogueOn pages covering devices included in the accepted mandate.
- Distributor dossierAs a verifiable representation status during onboarding and due diligence.
- Sales presentationFor procurement, partner meetings and trade-fair communication.
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.
Before you enquire
Know what shapes the review and the fee.
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.
Device and portfolio
Classification, IVD or medical device route, number of families, intended purpose and higher-risk features.
Evidence readiness
Technical documentation, clinical or performance evidence, quality-system records, certificates and labelling.
Ongoing responsibility
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.
01
Legal manufacturer
Confirm the entity, country of establishment, device family and intended EU market.
02
Core evidence
Have the classification rationale, technical-file index, conformity route and quality evidence available.
03
Post-market readiness
Identify complaint, vigilance, field-safety and authority-response owners before the mandate begins.
Typical review scenarios 01 02 03
The questions we resolve before a mandate starts.
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.
New EU launch
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.
Change of EC REP
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.
Higher-risk review
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.
Regulatory briefings
EUDAMED · Article 123(3)
Cyber Resilience Act
Article 10a MDR
Manufacturers outside the EU
The obligations manufacturers outside the Union ask about most.
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.
Device data falls due on 27 November 2026.
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 →Reporting duties start on 11 September 2026.
Products covered by the MDR are excluded. Companion software without a medical purpose, portals and service tools are not.
Read the cybersecurity briefing →Withdrawing a device now takes six months of notice.
The notice goes to the authority of the Member State where the manufacturer or its authorised representative is established.
Read the supply briefing →Not every part of a domestic file has to be rebuilt.
What transfers into a European file, what has no equivalent at home, and where a representative is required by law.
Open the compliance hub → Published acceptance criteria
Six tests every device scope must pass.
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.
- 01
Verified legal manufacturer and scope
The legal entity, authorised signatory, manufacturing sites, device families, models and intended purposes are consistent and traceable.
- 02
Defensible EU regulatory route
The qualification, classification and conformity-assessment route are documented, with valid notified-body involvement where required.
- 03
Controlled regulatory evidence
The EU declaration, agreed technical-documentation index, certificates, labelling and registration data describe the same device scope.
- 04
Working safety and post-market controls
Risk management, surveillance, complaints, vigilance, recalls and corrective actions have current records, owners and escalation routes.
- 05
Responsive manufacturer relationship
Named decision-makers can provide records, samples and technical answers and can act within agreed authority-response times.
- 06
Liability and continuity secured
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.
Meet MEDDEV in your own time zone. Live reference times for manufacturer markets. MEDDEV’s registered office is in Warsaw.
Request a 30-minute online meeting Vancouver–:–
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The people behind your mandate
Director-level governance. Named specialists for regulatory execution.
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.
MEDDEV Compliance sp. z o.o. · Warsaw, European Union ul. Mydlarska 47, 04-690 Warszawa, Poland biuro@meddev.pl
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Mikołaj Junosza-Szaniawski
Managing Director · EC REP Operations & GovernanceMikołaj 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.
25+ years at KPMG Director, Audit Assurance MBA · Carlson School of Management Specialist LCA training · MIT ESG lecturer · Kozminski University Programme manager · EPD Polska
One accountable contact, specialist depth when the device requires it.
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.
Regulatory affairsQuality systemsClinical evaluationPhysiciansBiomedical engineeringSoftware and cybersecurityAesthetic devicesPost-market surveillance
Marta Junosza-Szaniawska
Conformity assessment & EC REP mandate reviewMarta 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 Jęcka-Izdebska
Registration, notifications & ongoing coordinationBarbara 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