EU MDR Importer & Distributor Obligations: Complete Guide to Articles 13, 14, and 16

Comprehensive guide to EU MDR importer and distributor obligations under Articles 13, 14, and 16 — including EUDAMED registration, labeling requirements, QMS obligations, verification checklists, and the MDCG 2021-27 Q&A guidance for economic operators.

EU MDR Expanded Economic Operator Obligations Beyond What the MDD Required

The EU Medical Device Regulation (MDR 2017/745) introduced the formal concept of "Economic Operators" and dramatically expanded the obligations for every entity in the medical device supply chain. Under the old Medical Device Directive (MDD 93/42/EEC), importers and distributors had minimal defined responsibilities. The MDR now assigns them detailed, enforceable duties under Articles 13, 14, and 16 — with direct liability for non-compliance.

Understanding these obligations is critical because the consequences of getting them wrong are severe: market withdrawal, competent authority enforcement action, and joint and several liability for defective devices under Article 10(16). This guide covers every obligation in detail, explains when a distributor becomes an importer, clarifies the Article 16 relabeling and repackaging QMS requirements, and incorporates the latest MDCG 2021-27 Rev1 guidance.

Economic Operators Defined: The Four Roles

Article 2(37) of the MDR defines an Economic Operator as a manufacturer, an authorized representative, an importer, or a distributor. Each role carries distinct obligations, and a single entity can hold multiple roles simultaneously.

Role	Definition (Article 2)	Key Obligations Article	Must Register in EUDAMED
Manufacturer	Any natural or legal person who manufactures or fully refurbishes a device and markets it under their name or trademark	Article 10	Yes (Actor + Device)
Authorized Representative	Any natural or legal person established in the EU who has received a written mandate from a manufacturer to act on their behalf	Article 11	Yes (Actor)
Importer	Any natural or legal person established in the EU that places a device from a third country on the EU market	Article 13	Yes (Actor)
Distributor	Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market	Article 14	No (but must cooperate)

Critical Distinction: Importer vs. Distributor

The line between importer and distributor is determined by one fact: where does the device come from?

An importer is the entity that first places a device from a non-EU country onto the EU market. If you buy directly from a manufacturer outside the EU (US, China, Japan, etc.) and bring the product into the EU, you are the importer.
A distributor handles devices already on the EU market. If you buy from an EU-based importer or another EU distributor and resell, you are a distributor.
Both roles can apply simultaneously. If an EU-based entity buys directly from a non-EU manufacturer AND also buys from EU-based suppliers, it is an importer for the first category and a distributor for the second. Both Article 13 and Article 14 obligations apply to the respective products.

The MDCG 2021-27 Q&A document confirms that a community pharmacy, individual shop, retailer, or other person that buys and sells medical face masks to customers is a distributor under Article 14. However, if that same entity obtains devices directly from a non-EU manufacturer, it also assumes the role of importer and must comply with Article 13.

Personal Use Exception

A consumer who purchases a device in a third country for personal use is not considered to be "placing it on the market" and does not need to fulfill Article 13 or 14 obligations. This is confirmed in the MDCG 2021-27 guidance.

Importer Obligations Under Article 13

Article 13 defines ten specific obligations for importers. These are mandatory — not optional best practices.

Article 13(1) — Verify Conformity Before Placing on Market

Before placing a device on the EU market, the importer must verify that:

The device bears the CE marking
The manufacturer has drawn up the EU Declaration of Conformity (DoC)
The device is accompanied by the required information (IFU, labels) and labeled in accordance with the MDR
The manufacturer has appointed an Authorized Representative (for non-EU manufacturers)
The device has been assigned a UDI where applicable
The device is registered in EUDAMED in accordance with Article 29

Article 13(2) — Do Not Place Non-Conforming Devices

If the importer has reason to believe a device is not in conformity with the MDR, it must not place it on the market. If the device presents a serious risk or is a falsified device, the importer must immediately inform the competent authority of the Member State where it is established.

Article 13(3) — Labeling Requirements

The importer must indicate on the device, its packaging, or an accompanying document:

Its name, registered trade name, or registered trademark
Its registered place of business
The address at which it can be contacted

The additional label must not obscure any information provided by the manufacturer. This is a common failure point — importers must ensure their labeling does not cover critical manufacturer information.

Article 13(4) — EUDAMED Registration

Importers must verify that the device is registered in EUDAMED in accordance with Article 29 and must add their own details to the registration under Article 31. As of May 28, 2026, EUDAMED actor registration is mandatory for all importers, with the four key modules (Actor Registration, Device Registration, UDI/Device, and Certificates) confirmed as fully functional by the European Commission in November 2025.

Article 13(5) — Storage and Transport Conditions

Importers must ensure that storage and transport conditions do not jeopardize the device's compliance with the General Safety and Performance Requirements (GSPR) in Annex I. This obligation applies while the device is under the importer's responsibility.

Article 13(6) — Complaint and Non-Conformity Register

Importers must keep a register of:

Complaints
Non-conforming devices
Recalls and withdrawals

They must provide this information to the manufacturer, authorized representative, and distributors upon request to support complaint investigations.

Article 13(7) — Non-Conformity Action

When an importer considers or has reason to believe a device it has placed on the market is not conforming, it must:

Immediately inform the manufacturer and authorized representative
Inform the importer if applicable
Cooperate with all parties on corrective action
If the device presents a serious risk, also inform the competent authority

Article 13(8) — Incident Reporting

Importers who receive complaints or reports from healthcare professionals, patients, or users about suspected incidents must immediately forward this information to the manufacturer and its authorized representative. This creates a dual vigilance obligation — both the manufacturer and the importer must act on safety signals.

Article 13(9) — Record Retention

Importers must keep a copy of the EU Declaration of Conformity and, if applicable, any relevant certificates (including amendments and supplements) for the period defined in Article 10(8) — typically at least 10 years (15 years for implantable devices) after the last device was placed on the market.

Article 13(10) — Competent Authority Cooperation

Importers must provide competent authorities, upon request, with all information and documentation necessary to demonstrate device conformity, in a language determined by the Member State.

Distributor Obligations Under Article 14

Distributor obligations mirror many importer requirements but with key differences reflecting their position in the supply chain.

Article 14(1) — Verification Before Making Available

Before making a device available on the market, distributors must verify that:

The device bears the CE marking
The device is accompanied by the required information (IFU, labels) per Article 10(11)
For imported devices, the importer has complied with Article 13(3) labeling requirements
A UDI has been assigned by the manufacturer where applicable

Distributors may use a sampling method for verification (points a, b, d), but the sampling must be representative of the devices they supply. However, the importer's particulars (point c) must be verified for each device individually.

Article 14(2) — Do Not Make Non-Conforming Devices Available

If a distributor has reason to believe a device does not conform to the MDR, it must not make it available until it has been brought into conformity. If the device presents a serious risk or is a falsified device, the distributor must also inform the competent authority.

Article 14(3) — Storage and Transport

Distributors must ensure that storage and transport conditions comply with the manufacturer's specified conditions while the device is under their responsibility.

Article 14(4) — Non-Conformity Reporting

Distributors who consider or have reason to believe a device they made available is not conforming must:

Immediately inform the manufacturer and authorized representative
Inform the importer
Cooperate on corrective action (withdrawal, recall, etc.)
If the device presents a serious risk, also inform the competent authority

Article 14(5) — Record Keeping

Distributors must keep records of complaints, non-conforming devices, recalls, and withdrawals, and provide information to the manufacturer and authorized representative upon request.

Article 14(6) — Competent Authority Cooperation

Distributors must provide information and documentation to competent authorities upon request.

Importer vs. Distributor Obligations: Comparison Table

Obligation	Importer (Art. 13)	Distributor (Art. 14)	Difference
Verify CE marking	Yes	Yes	Same
Verify DoC	Yes	Yes	Same
Verify labeling/IFU	Yes	Yes	Same
Verify AR appointment	Yes	No	Importer only
Verify UDI assignment	Yes	Yes	Same
Verify EUDAMED registration	Yes	No	Importer only
Add own details to device label	Yes	No	Importer only
Register in EUDAMED (Actor)	Yes	No	Importer only
Storage/transport conditions	Yes	Yes	Same
Maintain complaint register	Yes	Yes	Same
Forward incident reports	Yes	No (inform manufacturer)	Importer has direct vigilance role
Keep copy of DoC/certificates	Yes	No	Importer only
Sampling-based verification	No (must verify each)	Yes (for most checks)	Distributor has more flexibility
QMS requirement (basic)	Implied	Implied	Neither explicitly required unless Art. 16 applies

Article 16: When Importers and Distributors Become Manufacturers

Article 16 is the provision that catches many economic operators off guard. It describes situations where an importer or distributor assumes the obligations of the manufacturer.

Article 16(1) — Assuming Manufacturer Status

An importer, distributor, or other person becomes the manufacturer if it:

Makes a device available on the market under its own name, registered trade name, or registered trademark (unless an agreement with the original manufacturer preserves the manufacturer's designation and responsibility)
Changes the intended purpose of a device already on the market
Modifies a device already on the market in a way that compliance with applicable requirements may be affected

Exception: Assembly of devices already bearing the CE mark into a system or procedure pack does not trigger Article 16(1) if the assembly is in accordance with the manufacturers' instructions and the intended purpose remains unchanged.

Article 16(2) — Translation and Repackaging

If an importer or distributor translates labels or IFUs, or repackages devices, Article 16(2) applies. These activities are permitted but subject to conditions under Article 16(3) and (4).

Article 16(3) — QMS Requirements for Repackaging/Translation

When an importer or distributor engages in repackaging or translation activities, it must:

Have a quality management system in place that includes procedures to ensure:
- Accurate and up-to-date translations (including mechanisms for the manufacturer to notify changes)
- Repackaging does not affect the original condition of the device
- New packaging is of adequate quality
Ensure activities do not compromise UDI carrier readability
Ensure the specific procedures are part of the QMS

Article 16(4) — Notified Body Certificate

The distributor or importer must:

Inform the manufacturer and the competent authority of the intention to make the relabeled/repackaged device available at least 28 days before market placement
Provide the manufacturer or competent authority, on request, with a copy or mock-up of the relabeled/repackaged device, including labels and translated IFUs
Obtain a certificate from a Notified Body attesting that the QMS complies with Article 16(3) requirements, at least 28 days before making the device available

This Notified Body certificate requirement is a significant new obligation that did not exist under the MDD. The QMS does not need to be ISO 13485 certified, but it must be assessed by a Notified Body designated for the type of device being relabeled or repackaged.

EUDAMED Registration Requirements for Importers

EUDAMED registration is a critical compliance step for importers. Here is the practical process:

Step 1: Obtain a Single Registration Number (SRN)

Before registering in EUDAMED, the importer must obtain an SRN from its national competent authority. The SRN uniquely identifies each economic operator in the EUDAMED system.

Step 2: Actor Registration

Company name, address, and contact details
Evidence of legal entity status (commercial register number)
Role designation (importer)
National competent authority

Step 3: Verify Device Registration

Under Article 13(4), importers must verify that each device they import is registered in EUDAMED by the manufacturer (Article 29) and then add their own details to the registration.

Step 4: Maintain Registration

Importers must update their EUDAMED registration when any information changes. The manufacturer is responsible for updating device records within 30 days of any change.

EUDAMED Timeline

Milestone	Date
EUDAMED Actor Registration module operational	2020
European Commission confirms 4 modules fully functional	November 2025
Mandatory actor registration for new devices	May 28, 2026
Legacy device registration deadline	Varies by class (2027-2028)

Legacy Device Requirements for Importers and Distributors

The MDR transitional provisions (as amended by Regulation 2023/607) affect importer and distributor obligations for legacy devices — those previously certified under the MDD or AIMDD:

Legacy Device Type	Importer Art. 13 Obligations	Distributor Art. 14 Obligations
Class III / Class IIb implantable (certificates valid to May 2026)	Art. 13(1)(a)-(f) APPLICABLE	Fully applicable
Class IIb (non-implantable) / Class IIa (valid to Dec 2027)	Art. 13(1)(a)-(f) APPLICABLE	Fully applicable
Class I devices under MDD	Art. 13(1) limited applicability	Fully applicable
Custom-made devices	Art. 13(4) APPLICABLE (verify EUDAMED registration)	Art. 13(5) NOT APPLICABLE

The MDCG 2021-27 Rev1 provides detailed Q&A on which specific Article 13 provisions apply to legacy devices.

Practical Compliance Checklist for Importers

Use this checklist to verify your import operations comply with EU MDR Article 13:

Verified device bears CE marking before first import
Confirmed EU Declaration of Conformity exists and is current
Verified the manufacturer has appointed an Authorized Representative in the EU
Confirmed labeling and IFU comply with MDR requirements (correct languages, symbols, information)
Verified UDI has been assigned by the manufacturer
Registered your company as an actor in EUDAMED (SRN obtained)
Added your importer details to device registration in EUDAMED
Applied importer name, trade name, and address to device or packaging
Confirmed additional label does not obscure manufacturer information
Established storage and transport procedures meeting manufacturer specifications
Created and maintain a complaint register
Created and maintain a non-conforming device register
Created and maintain a recall and withdrawal register
Established process to forward incident reports to manufacturer and AR immediately
Retained copies of DoC and certificates for required period (10 or 15 years)
Established process to respond to competent authority information requests

Practical Compliance Checklist for Distributors

Verified device bears CE marking (sampling method acceptable)
Confirmed IFU and labels are present and in required languages
Verified importer's name and address appear on imported devices (each device, not sampling)
Verified UDI has been assigned (sampling method acceptable)
Confirmed storage and transport conditions meet manufacturer requirements
Established complaint recording process
Established non-conformity reporting process (to manufacturer, AR, and importer)
Established process to inform competent authority of serious risk devices
Prepared to provide information to competent authorities upon request

Penalties and Enforcement

The MDR does not specify uniform penalties — enforcement is left to individual Member States under Article 113. However, penalties across EU Member States can include:

Fines: Varying by Member State, but can reach hundreds of thousands of euros for serious violations
Market withdrawal: Competent authorities can order removal of non-compliant devices
Sales bans: Prohibition on selling specific devices or all devices from a non-compliant operator
Import suspension: Blocking entry of devices at customs
Criminal liability: In some Member States, repeated or willful non-compliance can trigger criminal proceedings

Under Article 10(16), manufacturers are jointly and severally liable with importers and distributors for defective devices. This means a competent authority can pursue any economic operator in the supply chain for damages, and that operator must then seek contribution from others.

Frequently Asked Questions

Can a single device model have multiple importers?

Yes. The MDCG 2021-27 confirms that multiple importers can exist for the same device model from the same manufacturer. Each entity that independently imports a device from outside the EU assumes the full importer role and obligations for those units.

Is a community pharmacy that sells face masks a distributor?

Yes. The MDCG guidance explicitly states that community pharmacies, individual shops, retailers, and other persons who make a device available on the market up to the point of putting it into service are distributors under Article 14. If the pharmacy also imports directly from outside the EU, it is additionally an importer under Article 13.

Do distributors need a QMS under the MDR?

Not in general. Article 14 does not explicitly require a QMS for standard distribution activities. However, if the distributor engages in translation, relabeling, or repackaging under Article 16(2), then a QMS is required under Article 16(3), and a Notified Body certificate is needed under Article 16(4).

What happens if the importer cannot verify EUDAMED registration because the manufacturer has not registered the device?

The importer should not place the device on the market under Article 13(2). The importer must inform the manufacturer and, if the issue is not resolved, inform the competent authority. EUDAMED registration became mandatory for new devices on May 28, 2026.

Do importer obligations apply to devices imported for clinical investigations?

Devices imported specifically for clinical investigations under Article 62 are subject to different requirements (the clinical investigation application process). Standard importer obligations under Article 13 apply to devices placed on the market for commercial distribution, not investigational devices.

Can a non-EU company be an importer under the MDR?

No. Article 2(27) defines an importer as "any natural or legal person established within the Union." A non-EU entity cannot be an importer. The EU-based entity that receives the goods from outside the EU and places them on the EU market is the importer.

What records must importers retain and for how long?

Importers must keep a copy of the EU Declaration of Conformity and any relevant certificates (with amendments and supplements) for the period specified in Article 10(8): at least 10 years after the last device was placed on the market, or 15 years for implantable devices.

Does the distributor need to register in EUDAMED?

No. Distributors do not register in EUDAMED as actors. However, they must cooperate with manufacturers and importers who do register, and they must be prepared to provide information to competent authorities upon request.

What if our company is both importer and distributor for different products?

You must comply with both Article 13 (for imported products) and Article 14 (for EU-sourced products) simultaneously. The obligations apply based on the source of each specific device, not based on your company's primary role.

How does the MDR proposed revision affect importer/distributor obligations?

The European Commission's proposed MDR revision (expected adoption Q2 2027) introduces cybersecurity vulnerability reporting obligations for economic operators aligned with the Cyber Resilience Act, and clarifies the interplay between MDR and CRA requirements. Importers and distributors should monitor these changes for additional reporting obligations.