Our name goes on the label only after your file stands up to review.
Türkiye is inside the EU–Türkiye Customs Union. In its March 2022 notice to stakeholders the European Commission confirms that a manufacturer established in Türkiye has no obligation to designate an authorised representative in the Union in order to place medical devices on the EU market, and that a device covered by a certificate duly issued by a Türkiye notified body may circulate freely in the EU. An EU representative can still be appointed by choice, and becomes a legal requirement when the legal manufacturer is established outside the EU, the EEA and Türkiye. MEDDEV establishes which case applies before proposing anything.
For Turkish medical-device and IVD manufacturers preparing EU market entry, transferring an existing mandate or coordinating EUDAMED responsibilities.
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Most guidance written for third-country manufacturers does not apply to Türkiye. Decisions Nos 1/95, 2/97 and 1/2006 of the EC–Türkiye Association Council, together with the Joint Committee statements of 21 May 2021 and 13 September 2021, confirm that Turkish legislation is aligned with Regulations (EU) 2017/745 and 2017/746, and that references to the territories of the Parties are read as the territory of the Customs Union. MEDDEV starts by establishing which side of that line the legal manufacturer actually sits on.
The Commission states that manufacturers established in Türkiye have no obligation to designate an authorised representative on EU territory in order to place medical devices on the EU market. The reverse is also true: EU manufacturers need no representative in Türkiye. Any provider telling a Turkish manufacturer that an EC REP is legally required is misreading the Customs Union.
Türkiye is entitled to designate notified bodies under Regulations 2017/745 and 2017/746, and under Decision No 1/2006 may designate more than one. A notified body established in Türkiye has the same rights and obligations as one established in the EU, and devices covered by a certificate it duly issued may circulate freely in the EU.
A manufacturer established outside the EU, the EEA and Türkiye designates one authorised representative — in the EU or in Türkiye — to place devices on either market. Group structures, contract manufacturing and own-brand labelling are where this is most often misjudged, because the entity on the label is not always the entity established in Türkiye.
Related briefing: Your ÜTS records answer most of the questions EUDAMED asks. Which device data maps across, and which level is usually missing.
Official basis: Türkiye ÜTS: medical-device product tracking system, European Commission: EU–Türkiye Customs Union and medical devices, European Commission: authorised representatives, MDR Article 11, European Commission: EUDAMED UDI/Device registration.
For manufacturers in Türkiye, the EU–Türkiye relationship can create confusion between customs arrangements and medical-device conformity. MEDDEV separates the customs and distribution question from the MDR or IVDR route, then verifies the legal manufacturer, device scope and applicable EUDAMED responsibilities.
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 legal manufacturer’s place of establishment, evidenced rather than assumed: registration details, signatory powers and the entity named on the label and declaration.
Certificates issued by a notified body, with the designation checked against the current NANDO entry for the body and the procedure.
EU classification rationale, intended purpose and the conformity route the certificate actually covers.
ÜTS records for the device families concerned, and product-liability insurance covering the Union market.
Turkish manufacturers are routinely offered EC REP mandates as a legal requirement. Where the legal manufacturer is established in Türkiye it is not one. A mandate may still be worth having — for a single EU-facing contact, or to coordinate EUDAMED and vigilance work — but it is a commercial decision, not a legal necessity. Note that appointing a representative under Article 11 is not a light arrangement: it carries a defined statutory mandate, and the registration obligations themselves remain the manufacturer’s.
Whether a representative is needed follows the place of establishment of the legal manufacturer — not the shipping address, the group headquarters or where the goods clear customs. Where the entity named on the declaration is established outside the EU, the EEA and Türkiye, one representative must be designated.
A certificate supports only what it actually covers, and only while it remains valid. MDR certificates run for a defined period and can be suspended, restricted or withdrawn. Device families added after certification, or intended purposes broadened for the EU market, fall outside it.
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.
Confirm where the legal manufacturer is established and whether the Customs Union rules apply. This determines whether representation is a legal obligation, a commercial option or irrelevant.
Check the notified body’s designation, the procedures it covers and whether the certified scope matches the portfolio intended for the Union market.
Where a mandate makes sense, MEDDEV accepts it after the usual file, insurance and sanctions review. Where it does not, we say so and set out what actually needs attention.
No. ÜTS is the Turkish product tracking system and records local-market status. Union market access follows the conformity assessment and the certificate, which under the Customs Union may have been issued by a Turkish or an EU notified body.
Yes, where the body is designated for the relevant Regulation and the relevant procedure and device codes. The Commission states that a notified body established in Türkiye has the same rights and obligations as one established in the EU, and that devices covered by a certificate duly issued by it may circulate freely in the EU. Two things need checking, not one: the body’s current designation in NANDO, and the certificate’s own validity and status. A certificate is also not a market authorisation — the declaration of conformity, CE marking, labelling, UDI and the applicable EUDAMED entries still have to be in place.
Then the Customs Union position does not help you. A manufacturer established outside both the EU and Türkiye must designate one authorised representative, in the EU or in Türkiye. This is the single most common misreading we see, and it is worth settling before anything is printed on a label.
Not as a legal obligation. The European Commission states that manufacturers established in Türkiye have no obligation to designate an authorised representative on EU territory in order to place medical devices on the EU market, because Türkiye lies within the Customs Union. Where the legal manufacturer is established outside the EU, the EEA and Türkiye, one representative is designated — in the EU or in Türkiye. MEDDEV confirms where the legal manufacturer is established before any mandate is discussed, and will say so plainly if a mandate is not required.
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