MDCG Guidance on Articles 13 & 14 of MDR and IVDR: Obligations

The Medical Device Coordination Group (MDCG) has published a questions-and-answers guidance document (MDCG 2021-27 Rev. 1) dedicated to Articles 13 and 14 of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). The first revision was released on December 21, 2023, adding six new Q&As and updating three existing ones, making it the most current authoritative guidance on importer and distributor obligations in the EU.

The document is intended to assist medical device manufacturers and other parties in interpreting applicable regulatory requirements and ensuring compliance with the existing legal framework.

Definition and Roles of Importers and Distributors

First of all, the document provides definitions of the principal terms used when referring to the key parties involved as per Article 2 of the MDR (and corresponding IVDR articles):

• An “importer” is a natural or legal person in the EU that places a device from a third country on the EU market.
• A “distributor” is a natural or legal person in the supply chain, aside from the manufacturer or importer, who makes a device available on the market up until it is put into service.

Additionally, the document refers to several other key terms, such as “making available on the market”, “placing on the market”, and “putting into service”, to clarify these roles further.

Rev. 1 clarifies an important restriction: the same natural or legal person cannot simultaneously act as both importer and distributor for the same individual device. This is because the distributor is defined as any natural or legal person in the supply chain other than the manufacturer or the importer; meaning the two roles are mutually exclusive for a single device unit.

Determining the Role as Distributor or Importer

According to the document, a significant distinction between a distributor and an importer lies in “placing on the market”. A natural or legal person in the EU who obtains a device from a third country and is the first to make it available in the EU market acts as an importer.

Conversely, the ones who supply devices already available on the EU market for further distribution are considered distributors. It is also important to mention that a consumer who buys a device in a third country for personal use is not seen as placing it on the market. Therefore, such consumers do not need to fulfill obligations under Article 13 or 14 of the Regulations.

Rev. 1 adds further precision: where a natural or legal person sources devices from importers, distributors, or EU-established manufacturers and further distributes them to other entities, they are considered distributors. The operation of “making available” includes any supply of a device for distribution, consumption, or use on the EU market in the course of a commercial activity, whether in return for payment or free of charge.

EU-Based Distributors as Importers

The document confirms that an EU-based distributor becomes an importer if it obtains products directly from a non-EU manufacturer or distributor.
The critical factor is the “first making available” of the device on the EU market, which determines the role of an importer.

Rev. 1 also addresses a scenario specific to system and procedure packs (SPPs): an operator who assembles an SPP using devices sourced from a third-country manufacturer not yet placed on the EU market will be considered the importer of those individual devices, and must fulfil the obligations under Article 13 of the MDR. However, once those devices are included in the SPP, that same operator is considered a distributor of the individual devices in the pack.

Multiple Importers for a Single-Device Model

The MDCG states that a single device model from one manufacturer can have multiple importers. Each entity that meets the definition of an importer as per the MDR/IVDR and places an individual product on the market assumes the role and responsibilities of an importer.

This can happen regardless of whether another importer for the same model exists within the EU.

The guidance confirms that multiple importers can exist for a single device model. However, it is not possible to have multiple importers of the same individual device; the concept of placing on the market refers to each individual product, not the product type.

Each entity placing an individual unit on the EU market assumes the role and obligations of an importer for that specific unit.

Retailers and Community Pharmacies as Distributors

The document states that individual shops, community pharmacies, retailers, or other persons can be considered distributors. This classification applies if they make a device available on the market up to the point of putting it into service.

For instance, a community pharmacy that buys and sells medical face masks falls within the definition of a distributor. These entities must comply with Article 14 of the Regulations and any applicable national registration requirements.

Furthermore, suppose such operators obtain a device directly from a non-EU-based manufacturer or distributor. In that case, they also assume the responsibilities of an importer and must comply with Article 13 of the Regulations.

Rev. 1 also addresses how distributors must carry out their verification obligations. Physical checks of products are essential for detecting non-compliance.

If a distributor cannot perform a physical check without compromising the integrity of packaging or device compliance, verification may, in exceptional cases only, be based on documentation checks. Distributors should be prepared to demonstrate to the competent authority that verifications were carried out, and outsourcing verification to a subcontractor does not relieve the distributor of its legal obligations.

Conclusion

MDCG 2021-27 Rev. 1 provides essential, updated guidance for any company operating in the EU medical device supply chain. Whether your organization functions as an importer, distributor, or fulfillment service provider, or transitions between these roles, understanding the distinctions clarified by the December 2023 revision is fundamental to MDR and IVDR compliance.

With the EU’s broader simplification proposals moving through the legislative process and EUDAMED’s mandatory modules taking effect in May 2026, now is a critical time for supply chain actors to review their obligations under Articles 13 and 14 and ensure their internal processes reflect the latest guidance.

Source:

https://health.ec.europa.eu/system/files/2023-12/mdcg_2021-27_en.pdf

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Q&A:

1. What is the difference between an importer and a distributor under the EU MDR and IVDR? An importer is a natural or legal person established in the EU that places a device from a third country onto the EU market for the first time. A distributor is any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a device available on the market up until it is put into service. Critically, the same person or entity cannot simultaneously act as both importer and distributor for the same individual device, as the two roles are mutually exclusive.
2. How do you determine whether your company is acting as an importer or a distributor? The key distinction is whether your company is the first to make the device available on the EU market. If you are sourcing a device directly from a third country and introducing it to the EU market for the first time, you are acting as an importer. If you are supplying devices that are already available on the EU market for further distribution, you are acting as a distributor. Where a company sources devices from importers, distributors, or EU-established manufacturers and further distributes them, it is considered a distributor.
3. Can an EU-based distributor ever be considered an importer? Yes. An EU-based distributor becomes an importer if it obtains products directly from a non-EU manufacturer or distributor, since it would then be the first entity to make the device available on the EU market. The determining factor is always who is responsible for the “first making available” of the device on the EU market, that entity assumes the role and obligations of an importer, regardless of how they typically operate in the supply chain.
4. Can a single device model have more than one importer? Yes, a single device model can have multiple importers. Any entity that meets the definition of an importer and places an individual unit on the EU market assumes the role and obligations of an importer for that specific unit. However, a single individual device cannot have multiple importers; the concept of “placing on the market” applies to each individual product unit, not the product type as a whole.
5. Are community pharmacies and retailers considered distributors under the MDR and IVDR?Yes. Individual shops, community pharmacies, retailers, and similar entities can be classified as distributors if they make a device available on the market up to the point of it being put into service. For example, a community pharmacy that buys and sells medical face masks falls within the distributor definition and must comply with Article 14 of the Regulations. If such operators obtain devices directly from a non-EU manufacturer or distributor, they also take on importer obligations under Article 13.
6. What verification obligations do distributors have, and can they be outsourced? Distributors are required to carry out verification of the products they handle, and physical checks are considered essential for detecting non-compliance. In exceptional cases where a physical check would compromise the integrity of the packaging or device compliance, verification may be based on documentation checks only. Importantly, outsourcing verification to a subcontractor does not relieve a distributor of its legal obligations; distributors must still be prepared to demonstrate to the competent authority that verifications were carried out.
7. What is the importer’s role when assembling system and procedure packs (SPPs) using third-country devices? An operator who assembles a system or procedure pack (SPP) using devices sourced from a third-country manufacturer that have not yet been placed on the EU market is considered the importer of those individual devices and must fulfill the obligations under Article 13 of the MDR. However, once those devices are incorporated into the SPP, the same operator is then considered a distributor of the individual devices within the pack. This dual-role scenario was specifically clarified in the December 2023 revision of the MDCG guidance.
8. Does a consumer purchasing a device in a third country for personal use need to comply with importer obligations? No. A consumer who buys a device in a third country for personal use is not considered to be “placing it on the market” and therefore does not need to fulfill any obligations under Article 13 or 14 of the MDR or IVDR. These obligations apply only to commercial supply chain actors who make devices available on the EU market in the course of a commercial activity, whether for payment or free of charge.