Qualify the complete system
Device, software, accessories, communications, protective elements and non-medical functions are mapped before a conformity route is proposed.
EU Authorized Representative for field-medicine devices · MDR / IVDR Article 11 
Your EU representative for field-medicine medical devices. Built around the real operating environment.
Our name goes on the label only after your file stands up to review.
If the legal manufacturer is outside the EU, the Article 11 mandate starts with a controlled review of the product boundary, intended purpose, evidence and liability arrangements. Military use is not a regulatory shortcut.
For manufacturers of trauma, evacuation, portable diagnostic, monitoring, telemedicine and resilient medical technologies entering the European Union.
Illustrative context image of a deployable clinical environment. It does not depict a MEDDEV operation or imply institutional endorsement.
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
The regulatory starting point
The uniform does not determine the law. Intended medical purpose does.
A product built for military, civil-protection, emergency or humanitarian use is not automatically outside the MDR or IVDR. The first decision is whether the complete system is a medical device, IVD, PPE, software, another regulated product or a combination — and which claims are supported for the real environment.
Design for the actual conditions
Evidence should address transport, climate, power loss, cleaning, maintenance, pressured use and degraded connectivity rather than an ordinary-clinic assumption.
Build the Union control layer
Conformity work, an accepted EC REP mandate, EUDAMED, labelling and ongoing authority-response duties remain separately assigned.
Official basis: the MDR and IVDR determine scope by intended medical purpose and product characteristics. The European Defence Agency’s field-medicine work identifies pre-hospital care, field hospitals, training and simulation as distinct operational areas.
Products built beyond the ordinary clinic
01 02 03 04 05 06
One regulatory route for each intended use and system boundary.
The categories below are not legal classifications. They are the operating contexts in which product qualification, claims and evidence need particularly careful control.
Pre-hospital trauma care
Haemorrhage control, resuscitation, warming, infusion and other technologies used between the point of injury and field hospital.
Portable diagnostics
Point-of-care IVDs, imaging, physiological monitoring and diagnostic systems designed for constrained infrastructure.
Evacuation and life support
Transport monitoring, ventilation, oxygen, immobilisation and systems that must remain safe while patients and equipment move.
Telemedicine and connected care
Remote decision support, medical software, artificial intelligence and interoperable systems that must work with limited connectivity.
Field hospitals and logistics
Sterilisation, storage, environmental control, consumables and modular clinical systems used in deployable treatment facilities.
CBRN-related health technology
Diagnostics, protective or decontamination products whose legal route may cross medical-device, IVD, PPE and other Union frameworks.
EU regulatory base in Warsaw
Central European establishment. Regional operating context.
MEDDEV Compliance is legally established in Poland, inside the European Union. Warsaw is a practical coordination point for manufacturers serving Central and Eastern Europe and for projects serving Ukraine: the same Union legal framework, a nearby regional time zone and an accountable team that can work with both regulatory files and real deployment assumptions.
Poland is a deliberate regulatory home, not a loophole. Location can improve access, communication and response coordination. It does not reduce the MDR or IVDR conformity standard.
Map this device from Warsaw →
Standard route and exceptional route
STANDARD UNION ROUTE
AUTHORITY-CONTROLLED EXCEPTION
A narrow derogation exists. It is not a commercial fast track.
The standard conformity route remains the default for placing a portfolio on the Union market. For a specific device, however, MDR Article 59 or IVDR Article 54 allows a national competent authority to authorise market placement or use without completed conformity assessment when a duly justified request and the interest of public health or patient safety or health support that decision.
Built for repeatable commercial market access
Qualification, classification, technical and clinical or performance evidence, quality-system work, notified-body involvement where required, declaration, CE marking, EC REP, EUDAMED and supply-chain controls.
Built for a specific, justified need
In Poland, only the applicants named in Article 29 of the Medical Devices Act can request the permit. The President of URPL decides for the specific device and Polish territory. A manufacturer cannot buy or guarantee the decision.
Official basis: MDR Article 59, IVDR Article 54 and Article 29 of the Polish Medical Devices Act. MEDDEV specialists can assess whether the facts justify opening an exception workstream and map the evidence and authority interface; no derogation is promised.
Poland versus “the easiest country”
Choose the regulatory home. Do not shop for a lower standard.
EUDAMED is the Union’s one-stop registration system. It eliminates separate device submissions in different EU countries. A non-EU manufacturer registers with an active authorised representative; the representative verifies the request and the competent authority responsible for that representative assesses it.
Official basis: the European Commission’s EUDAMED overview and Actor registration guidance.
Why establish the EC REP relationship in Poland?
- An EU legal establishment and EU-wide actor identity.
- A responsible competent-authority relationship through Poland.
- Direct Central and Eastern European operating context.
- Practical proximity to projects and partners serving Ukraine.
- Named regulatory coordinators with specialist depth assigned by scope.
First technical review
Show how the device remains safe when ordinary assumptions fail.
The initial website form contains no document upload. After the parties and scope are confirmed, a controlled transfer route is provided for the evidence below.
- 01
Intended purpose, indications, contraindications, target population and the trained or non-professional user profile.
- 02
Qualification and classification rationale, including every connected accessory, software module and non-medical product function.
- 03
Environmental specifications for transport, vibration, temperature, humidity, dust, water, storage and expected service life.
- 04
Power, battery, connectivity, interoperability, data protection and cybersecurity assumptions under degraded conditions.
- 05
Cleaning, disinfection, sterility, maintenance, calibration and field-service arrangements for the actual deployment model.
- 06
Risk-management, usability, clinical or performance evidence and post-market plans that reflect the claimed operating environment.
Questions before deployment
What manufacturers should know before choosing the route.
Does military use exempt a medical device from the MDR or IVDR?
No general military-use exemption exists in the MDR or IVDR. The route depends on the product’s intended purpose and legal qualification. A system may also need assessment under other frameworks, for example where medical-device, IVD, PPE, machinery, radio-equipment or software elements meet in one product.
Is there a faster EU registration route for battlefield medical devices?
There is no routine fast-track registration for a defence customer or austere environment. MDR Article 59 and IVDR Article 54 allow a national competent authority to authorise a specific device without completed conformity assessment only on a duly justified request and when public health or patient safety or health supports the decision. It is an authority-controlled exception, not a manufacturer-selected launch route.
Who can request a conformity-assessment derogation in Poland?
Under Article 29 of the Polish Medical Devices Act, the closed list of eligible applicants comprises an entity performing medical activities, a statutory consultant in healthcare appointed under the Polish Act on consultants in healthcare, the President of the Agency for Health Technology Assessment and Tariff System, the President of the National Health Fund and the President of the Government Strategic Reserves Agency. The President of URPL decides whether to issue the permit for a specific device in Poland.
Does a Polish derogation automatically allow sales across the EU?
No. A national decision initially concerns the territory and scope stated by the competent authority. MDR Article 59 and IVDR Article 54 provide a separate Union-level mechanism through which the European Commission may extend a national derogation for a limited period. That extension is not automatic.
Is one EU country easier for registering a medical device?
The conformity requirements come from the same MDR or IVDR framework. EUDAMED is designed as a one-stop shop for actor and device registration across the EU and eliminates multiple device submissions in different Member States. National language, distribution and authority procedures can still differ, but selecting an EC REP in Poland does not lower the Union conformity standard.
What evidence matters for a device intended for austere environments?
The review should connect intended purpose and user profile with the real operating environment: transport and storage, temperature and humidity, power and connectivity loss, cleaning and sterility, usability under pressure, software and cybersecurity, interoperability, maintenance, risk controls and clinical or performance evidence.
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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Dubai–:–
Tokyo / Seoul–:–
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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
Check EC REP eligibility → 
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