Outcome first
One written route showing what is ready, what is missing, who owns each action and which items block EU market placement.
EU market entry for manufacturers outside the European Union 
Sell medical devices in Europe. Start with the correct EU route.
Our name goes on the label only after your file stands up to review.
If your legal manufacturer is outside the EU, appointing an EC REP may be mandatory — but it is not the entire launch route. MEDDEV maps the workstreams, reviews the agreed file and accepts the Article 11 mandate only when the criteria are met.
For medical-device and IVD manufacturers that want an accountable route into the European Union, with responsibilities and blocking gaps recorded in writing.
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
Direct answer
Selling medical devices in the European Union requires more than buying an address.
For a legal manufacturer established outside the EU, an EC REP is required when Article 11 of the MDR or IVDR applies. But representation comes after the device, conformity route and evidence are understood. MEDDEV begins with that map, then accepts the mandate only when the agreed file and liability criteria are met.
Representation with boundaries
MEDDEV acts as the EU Authorized Representative after acceptance. It does not replace the manufacturer, notified body, importer or distributor.
Ongoing control
The mandate covers defined EC REP duties, EUDAMED coordination, document access and authority communication throughout the agreed scope.
Official basis: the European Commission describes the duties of manufacturers, authorised representatives, importers and distributors and publishes a step-by-step factsheet for manufacturers.
EU launch route
01 02 03 04 05
Map my EU route →
Five workstreams between a home-market file and EU sales.
The exact sequence depends on the product and conformity route. These are the workstreams that must be assigned rather than collapsed into a single “registration” task.
Define the product
Confirm the intended purpose, medical-device or IVD status, classification and applicable MDR or IVDR route.
Complete conformity evidence
Organise the technical documentation, quality system, clinical or performance evidence and notified-body work where required.
Prepare the market release
Align the declaration of conformity, CE marking, UDI structure, labels and product families.
Appoint and register
For a non-EU manufacturer, appoint the EC REP when Article 11 applies and complete the applicable EUDAMED actor and device work.
Control the supply chain
Assign importer and distributor roles and maintain post-market surveillance, vigilance and authority-response processes.
Portfolio readiness
Prepare the evidence that determines the route.
The initial form contains no document upload. It qualifies the manufacturer and portfolio. MEDDEV provides a controlled transfer route after the parties and review scope are confirmed.
- 01
Legal-manufacturer extract, authorised signatory and manufacturing-site list.
- 02
Device list with intended purpose, classification and proposed EU launch countries.
- 03
Conformity route, current certificates and EU declaration of conformity draft.
- 04
Technical-documentation index, quality-system evidence and current labelling.
- 05
Post-market surveillance, vigilance and complaint-handling arrangements.
- 06
Product-liability insurance and the proposed EU importer structure.
Role clarity
What MEDDEV takes on — and what remains elsewhere.
MEDDEV
Pre-appointment review, an accepted Article 11 mandate, agreed verification and record duties, EUDAMED coordination and ongoing authority communication.
Manufacturer
Device conformity, technical-documentation accuracy, quality management, declarations, safety investigation, corrective decisions and truthful EUDAMED device data.
Other parties in the route
A notified body where the conformity route requires one, plus separately assigned importer and distributor duties in the Union supply chain.
Start from your home market
Choose the guide that matches the legal manufacturer.
Home-market evidence changes what can be reused, which databases remain separate and what must still be completed for the Union file.
United States
Map FDA status, QMS evidence and the proposed EU portfolio.
Open the manufacturer guide →Switzerland
Separate Swissmedic and swissdamed records from the Union route.
Open the manufacturer guide →Ukraine
Verify the legal manufacturer and map Ukrainian evidence to MDR or IVDR.
Open the manufacturer guide →Great Britain
Keep MHRA registration and EU representation as distinct workstreams.
Open the manufacturer guide →Canada
Map Health Canada, MDSAP and ISO 13485 evidence to the EU file.
Open the manufacturer guide →Australia & New Zealand
Use ARTG or WAND records as evidence, not as EU authorization.
Open the manufacturer guide →
Home market versus EU route
What can support the EU file — and what must be rebuilt.
The table is a starting map, not a conformity assessment. The exact answer depends on intended purpose, classification, device family and the evidence available for the proposed Union portfolio.
Origin
Home-market evidence
EU workstream
United StatesMap intended purpose and evidence before reusing FDA records.
FDA clearance, QMS evidence and US labelling
MDR/IVDR classification, EU conformity route, CE documentation, EUDAMED and EC REP
SwitzerlandReconcile Swiss and EU legal-manufacturer data.
Swissmedic / swissdamed records
Separate EU actor and device records; Swiss systems do not replace EUDAMED
Great BritainConfirm Great Britain versus Northern Ireland establishment.
MHRA registration and UK market records
Separate EU mandate, EU labelling and EUDAMED workstream
CanadaMap Canadian product families to the EU portfolio.
Health Canada, MDSAP and ISO 13485 evidence
MDR/IVDR route, EU declarations, labels and Union post-market duties
Australia / New ZealandKeep Australian and New Zealand legal manufacturers distinct.
ARTG or WAND records, depending on jurisdiction
Separate EU conformity and EUDAMED route
Japan / South KoreaBuild an evidence map instead of assuming equivalence.
PMDA/MHLW or MFDS/KGMP evidence
EU classification, clinical/performance evidence and MDR/IVDR labels
Saudi Arabia / UAEVerify the legal manufacturer and local-agent structure.
SFDA or local authority records
EU conformity, liability, importer and EUDAMED responsibilities
Ukraine / Türkiye / IsraelCheck continuity, signatory authority and device scope early.
National technical or market records
Separate Union route, Article 11 mandate and EU post-market duties
Next step: choose the country guide for the legal manufacturer, then submit the portfolio for a documented MDR or IVDR scope review.
Questions before EU launch
What “ready to sell” actually requires.
How can a manufacturer outside the EU sell medical devices in the European Union?
The manufacturer must identify the applicable MDR or IVDR route, complete the required conformity work, prepare compliant declarations and labelling, appoint an EU Authorized Representative when Article 11 applies and complete the applicable EUDAMED and supply-chain steps before market placement.
Does appointing an EC REP mean that a device is ready for EU sale?
No. The EC REP mandate is one part of the route. It does not replace conformity assessment, technical documentation, CE marking, an EU declaration of conformity, UDI and labelling work, importer verification or post-market obligations.
Can FDA, Swissmedic, Health Canada, TGA or other home-market evidence be reused?
Relevant quality, risk, clinical, performance and post-market evidence may support the EU file. MEDDEV maps it against MDR or IVDR rather than assuming that a home-market licence or registration creates EU conformity.
Does every medical device need a notified body?
No. The answer depends on the applicable regulation, device type, classification and conformity route. Where notified-body involvement is required, MEDDEV reviews the certificate and scope but does not act as the notified body or issue a conformity-assessment certificate.
What does MEDDEV review before accepting an EC REP mandate?
The review covers the legal manufacturer and device identity, intended purpose and classification, conformity route and certificates, the agreed technical-documentation index, quality-system evidence, labelling, post-market and vigilance arrangements, product-liability insurance and sanctions screening.
Is MEDDEV also the EU importer or distributor?
The EC REP mandate does not itself make MEDDEV the importer or distributor. Those are separate economic-operator roles with their own MDR or IVDR duties and must be assigned within the manufacturer’s supply chain.
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–:–
New York / Toronto–:–
Warsaw–:–
Dubai–:–
Tokyo / Seoul–:–
Sydney–:–
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
Map my EU route → 
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