Sell medical devices in the EU from Israel · MDR / IVDR Article 11

EU Authorized Representative for Israeli manufacturers.

Our name goes on the label only after your file stands up to review.

A manufacturer established in Israel 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 Israeli medical-device and IVD manufacturers preparing EU market entry, transferring an existing mandate or coordinating EUDAMED responsibilities.

Established in the European UnionWarsaw, Poland · EC REP under MDR and IVDR Article 11

Online intake Secure connection

Apply for MEDDEV mandate review

A short, three-step intake. We confirm eligibility, define the review scope and decide whether to proceed.

Step 1 of 3 · Manufacturer

Full name *

Work email *

Company (manufacturer) *

Regulatory route *

Country *

Device class *

No document upload at this stage · reply usually the same working day · in English

Confidential files are handled separately through one-time access, private EU storage and automatic deletion after expiry. Review our security and data handling controls.

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

Israel → European Union

The fastest road to the AMAR registry runs through Europe.

Israel’s Medical Equipment Law of 2012 lets the Ministry of Health’s Medical Equipment Division (AMAR) register a device on the strength of its registration — or marketing permission — combined with actual marketing in a recognized country: a statutory list that includes most of the older EU member states, the United States, Canada, the United Kingdom and Switzerland. The Ministry’s simplified declaration and fast-track routes are open only to such devices, and they describe risk classes in the European regulation’s own terms. In practice an Israeli manufacturer often completes the EU route — CE marking followed by real sales in a recognized country — before the home registration, which makes the EU work the critical path and the EC REP mandate part of the first market entry, not an afterthought.

Home registration is built on recognition of foreign approvals

Section 6(b) of the Medical Equipment Law 5772-2012 provides that where a device is registered, or permitted for marketing and actually marketed, in a recognized country, the Director registers it in the AMAR registry for a period not exceeding the foreign approval’s validity, up to five years. The schedule of recognized countries lists twenty-one states, including most of the older EU members, the US, Canada, the UK and Switzerland.

The simplified routes assume a recognized-country approval and sales record

AMAR’s declaration route for low-risk devices and its fast-track route for Class II devices and medium-risk IVDs apply only to devices registered and marketed in recognized countries, with the route determined by the risk class, the registering regulatory authority and the marketing history in the recognized country. The procedures classify devices using the European regulation’s classes and keep the CE certificate and the ISO 13485 certificate current in the registration file. A device manufactured in Israel with no recognized-country registration faces the full domestic dossier, including two independent expert medical opinions.

EU conformity is assessed on its own terms all the same

The recognition mechanism points from Europe into Israel, not the other way. The CE marking is obtained through MDR or IVDR conformity assessment — classification from the Union rules, technical documentation, clinical or performance evidence and, where required, a notified body. For a manufacturer established in Israel, Article 11 requires a sole authorised representative established in the Union as a condition of placing devices on the EU market.

Official basis: Israel Ministry of Health: the Medical Equipment Division (AMAR), Medical Equipment Law 5772-2012 (consolidated text, Hebrew), European Commission: authorised representatives, MDR Article 11, European Commission: EUDAMED UDI/Device registration.

Local review focus

What usually needs attention for Israel manufacturers.

Israeli manufacturers may have mature local-market evidence, but an EU review still tests the intended purpose, classification, clinical evidence and post-market process against MDR or IVDR. The key deliverable is a written map of reusable evidence and open Union-specific actions.

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
The legal manufacturer’s details and the proposed EU portfolio, with the intended purpose as it will be worded for the Union market and the MDR or IVDR classification rationale.
02
The technical documentation index: risk management file, clinical or performance evidence, labelling and the quality-system certificate — Israeli regulations themselves require manufacture under ISO 13485 conditions, so the certificate usually exists.
03
Any existing AMAR registration and the approvals it rests on, to keep the Israeli and EU records consistent as both files evolve.
04
Vigilance arrangements: the Israeli registration holder must report serious incidents in Israel and abroad, so the EU and Israeli reporting duties should be coordinated in one procedure.

Typical transition gaps

Issues to resolve before the mandate starts.

The registration holder read as an EC REP

Israeli law requires the registration application to be submitted by an Israel-resident contact person, and the certificate is issued to a registration holder with statutory duties, including incident reporting. That role points into the Israeli system. The EU authorised representative under Article 11 of the MDR or IVDR is a separate designation with its own statutory mandate and liability conditions — one does not stand in for the other.

ISO 13485 assumed to settle the QMS question

Israeli regulations require devices to be manufactured in a plant certified to ISO 13485, so Israeli manufacturers typically hold the certificate already. It is genuinely useful for the EU file, but the MDR and IVDR assess the quality system as part of conformity assessment — the certificate is evidence within that assessment, not a substitute for it.

Sequence planned market-by-market instead of once

Because the AMAR routes reward a recognized-country registration and sales record, the efficient order is usually: EU classification and conformity work first, then the Israeli registration on the strength of the EU record. Deciding the sequence late means either a slower home registration or duplicated evidence work.

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

From home-market records to EU representation.

Confirm the entity and the portfolio

Verify the legal manufacturer, signatories, device families and intended EU importers, and word the intended purpose for the Union market.

Run the EU file as the critical path

Set the MDR or IVDR classification and conformity route, complete the technical documentation review and, where required, the notified-body work — this, together with actual marketing in a recognized country, is what the Israeli registry can then recognize.

Accept and coordinate

Complete file, insurance and sanctions review, then coordinate the mandate, labelling and EUDAMED work — and keep the AMAR file consistent with the EU records.

Check this portfolio →

Questions from Israel

What manufacturers ask before appointment.

Should we register in Israel first or obtain CE marking first?

For most portfolios the practical answer is the EU first. Section 6(b) of the Medical Equipment Law registers a device in the AMAR registry on the basis of its registration — or marketing permission — and actual marketing in a recognized country, and the simplified declaration and fast-track routes are open only to such devices. A device that is CE-marked and genuinely sold in a recognized country can then be registered at home on that record; an Israel-made device without one goes through the longer domestic dossier. The sequencing is a decision for the manufacturer — what we can say is what each path requires.

Is our Israeli registration holder the same thing as an EU authorised representative?

No. The Israeli registration holder and the resident contact person operate within the Israeli system, with duties defined by Israeli law. The EU authorised representative is designated under Article 11 of the MDR or IVDR and is a condition of placing devices on the Union market for a manufacturer established outside it. The two roles should be coordinated — especially for vigilance — but neither replaces the other.

Does our ISO 13485 certificate under Israeli law satisfy the MDR?

It helps substantially, but it is not the end of the question. Israeli regulations require manufacture in an ISO 13485-certified plant, so the certificate is usually in place. Under the MDR or IVDR the quality management system is assessed as part of conformity assessment for the specific devices and processes concerned; the certificate is strong evidence within that assessment rather than a stand-alone pass.

Does every manufacturer from this country need an EC REP?

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.

What is reviewed before the mandate?

MEDDEV reviews the legal manufacturer, device identity, classification, conformity route, technical-documentation index, insurance, vigilance arrangements and sanctions screening.

Can documents be sent through the first contact form?

No. The form is for qualification only. A controlled document-transfer route is provided after scope and parties are confirmed.

Post-project client survey

Post-project ratings from real regulatory work.

56published post-project ratings

97%marked MEDDEV “recommended”

5/5 across five criteria WDI Wise Device Europe Readiness audit · 2015

5/5 across five criteria SensiMed Medical device notification · 2015

5/5 across five criteria Piórex S.A. Medical device registration · 2015

Historical MEDDEV post-project survey across regulatory services. Clients rated knowledge transfer, consultant engagement, subject-matter preparation, problem solving and overall service. The individual ratings shown here are from 2015; the summary figures cover the published set from that survey programme. Comments were optional, so most ratings carry none — and no quotation has been reconstructed or written on a client’s behalf.

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.

Example on a manufacturer website. The issued mark should link to the active MEDDEV mandate and its defined device scope.

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.

Legal manufacturer

Confirm the entity, country of establishment, device family and intended EU market.

Core evidence

Have the classification rationale, technical-file index, conformity route and quality evidence available.

Post-market readiness

Identify complaint, vigilance, field-safety and authority-response owners before the mandate begins.

Check your EC REP readiness →

Typical review scenarios

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

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.

EUDAMED · Article 123(3)

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 →

Cyber Resilience Act

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 →

Article 10a MDR

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 →

Manufacturers outside the EU

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.

Present my device scope →

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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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

Check my eligibility →

Mikołaj Junosza-Szaniawski

Managing Director · EC REP Operations & Governance

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.

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 review

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 Jęcka-Izdebska

Registration, notifications & ongoing coordination

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