Importing Investigational Medical Devices into the EU

Importing an investigational medical device into the European Union requires more than arranging international transport. Before shipment, the sponsor must align the clinical investigation authorisation, the device documentation and labelling, the applicable customs procedure, the party acting as importer of record, and the controls for storage, distribution and device accountability.

The EU Medical Device Regulation does not establish a single customs procedure specifically for investigational devices. The regulatory and customs pathways must therefore be planned together, with responsibilities assigned before the devices leave the country of origin.

Clinical Investigation Requirements and Customs Importation Are Different Processes

Sponsors should distinguish between three separate concepts:

Clinical Investigation Authorisation

A clinical investigation must follow the applicable requirements of Articles 62 to 80 and Annex XV of the EU MDR. Depending on the investigation, this may include applications to competent authorities and ethics committees, the Clinical Investigation Plan, the Investigator’s Brochure, evidence supporting device safety and performance, and the required insurance or indemnification arrangements.

A shipment should not be released to the investigation sites until the applicable regulatory and ethics requirements have been completed.

Customs Importer of Record

The importer of record is the party responsible for the customs declaration and the associated customs obligations. The appropriate party and customs procedure depend on factors such as the country of entry, ownership of the devices, intended use, declared value, duration of the investigation and whether the devices will be returned, destroyed or remain in the European Union.

This customs role must be agreed with a qualified customs broker or adviser before shipment.

MDR Article 13 Importer

The economic operator importer defined in Article 13 of the MDR is associated with devices placed on the Union market. This role should not automatically be treated as equivalent to the customs importer of record for an investigational device shipment.

The regulatory status of the devices and the customs role assigned to each party should be assessed separately and documented.

MDR Requirements to Address Before Shipment

Before investigational devices are shipped to the European Union, the sponsor should confirm the following points.

1. Clinical Investigation Authorisation

The sponsor should verify that the investigation has received the required competent authority and ethics approvals, or that the applicable notification procedure has been completed.

The authorisation status should be checked for every participating country. Approval in one Member State does not automatically authorise the investigation in another Member State.

2. EU Legal Representative

Under Article 62(2) of the MDR, a sponsor that is not established in the European Union must generally appoint a legal representative established in the Union.

The appointment, responsibilities and territorial coverage of the legal representative should be documented before the clinical investigation application is submitted. Read more about the EU legal representative requirement under MDR Article 62(2).

3. Applicable General Safety and Performance Requirements

Article 62(4)(l) requires the investigational device to comply with the applicable General Safety and Performance Requirements, except for the aspects covered by the clinical investigation.

For those aspects, every precaution must be taken to protect the health and safety of the subjects. The supporting technical, biological, preclinical and risk-management evidence should be consistent with the Clinical Investigation Plan and the Investigator’s Brochure.

4. Investigational Device Labelling

The labelling requirements for investigational devices are addressed specifically in Annex XV of the MDR.

The label must clearly identify the device as intended exclusively for clinical investigation and provide the information necessary for identification, traceability, safe use and management during the investigation. Applicable national language requirements must also be considered.

Commercial device labelling should not be reused without confirming that it meets the requirements applicable to the investigation.

5. Safety Reporting and Device Accountability

The sponsor must establish procedures for recording and reporting serious adverse events and device deficiencies in accordance with Article 80 and the applicable European guidance.

The shipment and distribution plan should also allow each device to be traced from dispatch through receipt, use, return or destruction. Lot numbers, serial numbers, quantities and destination sites should remain consistent across the shipping records and the clinical investigation documentation.

Choosing the Appropriate Customs Procedure

The appropriate customs procedure cannot be determined from the MDR alone. It depends on the intended movement and final disposition of the devices.

Possible routes may include release for free circulation or, when the legal conditions are met, a special customs procedure such as temporary admission.

Temporary admission may be relevant when non-Union goods are used in the European Union for a limited period and are intended for re-export. It is not automatic. Authorisation, guarantees, time limits and other conditions may apply.

Before shipment, the sponsor should confirm with its customs adviser:

The party acting as importer of record
Whether an EORI number is required and who will provide it
The customs classification and commodity code
The country of origin
The customs value, even when the devices are not being sold
The applicable duties and import VAT treatment
The Incoterms and allocation of customs responsibilities
Whether temporary admission or another special procedure is appropriate
How unused, returned, damaged or explanted devices will be handled
Which records must be retained after the customs procedure is discharged

Investigational use or the absence of a commercial sale does not remove the need to declare an appropriate customs value.

Planning Multi-Country Clinical Investigations

For a multi-country investigation, the sponsor should decide whether devices will enter the European Union through a central depot or be imported directly into individual countries.

A central entry point can simplify inventory control and subsequent distribution within the Union, but it does not replace country-specific clinical investigation approvals, language requirements or local site controls.

The distribution plan should define:

The initial EU point of entry
The central depot or receiving organisation
The destination sites in each country
The quantities allocated to each site
Storage and temperature requirements
Device accountability and reconciliation
The management of unused, returned or explanted devices
The final customs and physical disposition of the devices

The selected model should be reviewed against the customs, VAT, regulatory and operational requirements of every participating country.

Common Causes of Importation Delays

Investigational device shipments are commonly delayed when:

The customs importer and the MDR economic operator importer are treated as the same role without assessment
Devices are shipped before regulatory or ethics requirements are completed
The invoice does not provide a defensible customs value
The device description is too generic for customs classification
The investigational device label is incomplete
Device models, serial numbers or quantities differ between documents
Responsibilities under the selected Incoterms are unclear
The destination site is not prepared to receive or store the devices
No procedure has been defined for returns, destruction or re-export
Country-specific language or documentation requirements have not been checked

An importation plan should therefore be incorporated into study start-up activities rather than addressed only when the devices are ready to ship.

How a Medical Device CRO Can Support the Process

A medical device CRO can coordinate the regulatory and clinical activities associated with the shipment, including:

Clinical investigation strategy and submissions
EU legal representative coordination
Review of investigational device documentation and labelling
Alignment between the regulatory, clinical and logistics teams
Country and site readiness
Device accountability procedures
Safety reporting processes
Coordination with the sponsor’s customs broker and logistics providers

The customs declaration and importer-of-record responsibilities must still be assigned to appropriately qualified parties.

MDx supports sponsors with the planning and regulatory coordination of investigational device importation. MDx does not act as an economic operator importer as defined in Article 13 of the EU MDR. The party acting as customs importer of record must be identified separately for each importation model.

Frequently Asked Questions

Do investigational medical devices need a CE mark before entering the EU?

An investigational device does not necessarily need to be CE marked for the intended investigational use. However, the clinical investigation must comply with the applicable MDR requirements, and the device must meet the applicable General Safety and Performance Requirements except for the aspects being investigated. Appropriate precautions must be taken for those aspects.

Does Article 21 of the MDR establish the importation procedure?

No. Article 21 addresses the free movement of devices intended for clinical investigations when the applicable conditions have been met. It does not replace customs procedures or provide a complete operational importation process.

Is the customs importer of record the same as the MDR Article 13 importer?

Not necessarily. The customs importer of record is responsible for customs formalities. The Article 13 importer is an MDR economic operator associated with placing devices from a third country on the Union market. The application of each role must be assessed separately.

Can temporary admission always be used for investigational devices?

No. Temporary admission is subject to customs conditions and authorisation. Its suitability depends on the intended use, duration, ownership and final disposition of the devices. The planned procedure should be confirmed with a customs adviser before shipment.

Can one shipment be distributed to investigation sites in several EU countries?

A central import and distribution model may be possible, but the sponsor must still consider the clinical investigation authorisation, language, storage, accountability and local requirements of every participating country.

Plan Your EU Medical Device Clinical Investigation

Importation should be planned as part of study start-up, with the regulatory, customs, logistics and site teams working from the same device and distribution information.

MDx provides MedTech clinical solutions covering clinical investigation planning, regulatory submissions, EU legal representation, site readiness, monitoring and study oversight.

Contact MDx to discuss the regulatory and operational requirements of your European medical device clinical investigation.

Importing Investigational Medical Devices into the EU Under the MDR