Under Article 2(33) of Regulation (EU) 2017/745, an importer of medical devices is any natural or legal person established in the Union that places a product from a third country on the Union market. The importer is an independent economic operator with directly applicable obligations, not merely a logistics service provider. Article 13 assigns the importer a control function at the external border of the internal market: before placing the product on the market, the importer checks formal conformity features, remains responsible for storage and transport, and contributes to vigilance and corrective actions. Under certain conditions, the importer may fully assume the manufacturer’s obligations under Article 16.
Verification obligations before placing on the market
Before placing a product on the market, the importer must verify that the product bears the CE marking and that the EU declaration of conformity has been drawn up; that the manufacturer is identified and, where the manufacturer is established outside the Union, an authorised representative has been designated in accordance with Article 11; that the product is labelled in accordance with the Regulation and the required instructions for use are enclosed; and that a unique device identifier has been assigned to the product in accordance with Article 27.
If the verification gives rise to doubts about conformity, the importer must not place the product on the market and must inform the manufacturer and its authorised representative. If there is reason to believe that the product presents a serious risk or is a falsified product, the competent authority of the Member State in which the importer is established must also be informed.
Own details and registration
The importer must indicate on the product, on the packaging or in an accompanying document its name, its registered trade name or registered trade mark, its registered place of business and its address. In doing so, it must not obscure any information on the manufacturer’s labelling. The importer must also verify that the product is registered in the electronic system referred to in Article 29 and add its own details in accordance with Article 31; as a registered actor, it receives a single registration number.
Storage, records and forwarding
As long as a product is under its responsibility, the importer must ensure that storage and transport conditions do not compromise compliance with the general safety and performance requirements set out in Annex I and comply with the manufacturer’s instructions. The importer must keep a register of complaints, of non-conforming products, and of recalls and withdrawals, and provide the manufacturer and its authorised representative with the information they request.
The importer must forward complaints and reports of suspected incidents to the manufacturer and the authorised representative without delay and cooperate in corrective actions. A copy of the declaration of conformity and, where applicable, the certificate must be kept available for the retention period set out in Article 10(8).
Assumption of manufacturer obligations
Under Article 16, an importer assumes the manufacturer’s obligations if it makes a product available on the market under its own name or its own trade mark, changes the intended purpose of a product already placed on the market, or modifies a product in such a way that conformity may be affected. An exception applies to the use of the importer’s own name where there is a written agreement with the manufacturer stating that the manufacturer remains identified as the manufacturer.
Under Article 16(2), translating the information referred to in Annex I, Section 23, and changing the outer packaging, including pack size, are not considered modifications relevant to conformity. However, anyone carrying out such activities is subject to the notification, quality management and certification obligations under Article 16(3) and (4), which are described in more detail in the entry Distributor of medical devices.
Distinction from the authorised representative and the distributor
The authorised representative acts on behalf of a manufacturer established outside the Union and performs regulatory tasks in the manufacturer’s name; its role is described in the entry Authorized Representative. The importer, by contrast, acts in its own name and places the product on the market itself. Both roles may be combined within one company, but they remain legally separate and must be documented separately.
A distributor makes a product available without importing it from a third country. The decisive factor is therefore not the level in the supply chain, but who first places the product on the Union market.
Relevance for clinical trials
Investigational devices without CE marking are not placed on the market but are made available for a clinical investigation; the importer obligations under Article 13 do not apply to them in the same way. However, importing from third countries gives rise to comparable practical requirements: correct customs declaration, documented intended use, and a demonstrably maintained transport chain.
If, in an investigation, additional commercially available products are used as comparator or concomitant products, these are imported in the usual way and are subject to the full importer obligations, which affects complaint pathways and reporting obligations. Full-service CROs such as Mediconomics support sponsors and manufacturers in describing supply routes, responsibilities and reporting interfaces for investigational devices and comparator products in a way that meets both the requirements of the Regulation and site practice.
Frequently Asked Questions (FAQ)
Does the importer have to affix its details on the product itself?
Not necessarily. Article 13(3) allows the information to be provided on the product, on the packaging or in an accompanying document, but requires that the manufacturer’s information is not obscured.
Does an importer need a person responsible for regulatory compliance?
Article 15 imposes this obligation on manufacturers and authorised representatives. However, for registration under Article 31 and Annex VI, Part A, contact details must also be provided for importers, and if an importer assumes manufacturer obligations under Article 16, the full set of obligations applies to it.
How long must documentation be retained?
For the period set out in Article 10(8), i.e., at least ten years after the last product covered has been placed on the market, and at least fifteen years for implantable devices.
Regulatory References
- Regulation (EU) 2017/745, Article 2(33) — Definition of importer
- Regulation (EU) 2017/745, Article 13 — General obligations of importers
- Regulation (EU) 2017/745, Article 16 — Cases in which manufacturer obligations apply
- Regulation (EU) 2017/745, Article 31 and Annex VI, Part A — Registration of economic operators
- Regulation (EU) 2017/745, Article 10(8) — Retention periods
