Importers and Distributors: when Additional Duties Apply

Importers and distributors of medical devices are subject to the duties outlined in Articles 13 and 14 of Regulation (EU) 2017/745, respectively. However, if their activity is not limited to purchasing and making available on the market products exactly as received, they may be subject to additional duties.

This article outlines a guide, developed with reference to Article 16, that can help importers and distributors (hereinafter “the organization”) understand whether the activities they conduct on medical devices manufactured by third parties involve additional responsibilities beyond those prescribed by Articles 13 and 14.

Does the Organization Make Changes to the Devices or Perform Specific Activities Dedicated to Them?

If the organization limits itself to purchasing and making the product available on the market exactly as received, it is clearly not subject to obligations beyond those set out in Articles 13 or 14, depending on its role.

Otherwise, it is necessary to examine the extent of the activity carried out, as additional responsibilities may arise, as mentioned earlier.

Is a New Name, Trade Name, or Trademark Associated with the Device?

If the activity is subordinate to and regulated by an agreement with the manufacturer, and the manufacturer will continue to appear on the label and be responsible for complying with the obligations set out in the MDR, the organization is not subject to additional burdens beyond those set out in Articles 13 or 14, depending on its role.

If one of the above conditions is not met, the organization, on the contrary, assumes the role of manufacturer and the associated duties.

Is the Intended Purpose Modified?

If the intended purpose of the device is modified, the resulting product is to all intents and purposes a new medical device. The organization making this modification becomes the manufacturer and must therefore fulfill all related obligations.

Is the Device Assembled or Adapted for a Specific Patient?

When a device already on the market is assembled or adapted for a specific patient without changing its intended purpose, the organization carrying out this activity does not assume additional burdens beyond those related to the role of importer or distributor.

Is a Modification Made that could Compromise the Product’s Conformity with Applicable Requirements?

To give a correct answer to this question, given the variability and breadth of the topic, it is essential that the organization has a high level of knowledge about the product, its scope of marking, and the conformity assessment process it has undergone. This is because if the product’s conformity is compromised – and it is crucial to be able to determine this – the organization making the modification assumes the role of manufacturer of the modified medical device, with all the duties that follow.

There is also a scenario related to the replacement of parts and components of medical devices already placed on the market through the use of identical or similar “articles” to what they replace, manufactured and made available on the market by third parties other than the manufacturer. This activity is governed by Article 23 of Regulation (EU) 2017/745 and therefore deserves separate consideration.

Does the Modification Concern the Device Packaging?

In general, changes to the outer packaging of a device already placed on the market, including changes to packaging dimensions – if necessary to market the device in the Member State in question and if carried out under conditions that do not alter the original state of the device – are not considered to compromise the conformity of the product with applicable requirements.

Consequently, it is possible that the duties of the organization carrying out such activity remain those of Articles 13 and 14.

However, the above is not sufficient to complete the assessment: in this case too, it is necessary to consider the original scope of marking of the medical device involved in order to evaluate the extent of the modification and the applicability of additional duties.

Repackaging of Devices Purchased in Bulk

The most frequent case where repackaging results in an alteration of the original state of the device and the loss of consistency with the original scope of marking is the modification of packaging resulting from repackaging of devices purchased in “bulk” (large quantities or multiple packages).

For example:
The distributor Acme Corporation purchases syringes in bulk of 10,000 pieces (100 packages of 100 pieces) to resell on the Italian market.
The manufacturer Stark Industries, in its technical documentation, considers the 100-piece package as the CE-marked product, not the individual syringe.
The distributor Acme Corporation opens the 100-piece packages and creates 10 packages of 10 pieces, then places them on the market.

In this case, the individual syringe is not covered by the CE marking – which refers to the 100-piece package. The new package constitutes, in fact, a new device outside the scope of marking defined by the manufacturer.
Acme Corporation therefore assumes the role of manufacturer and the associated duties.

Does the Organization Provide and/or Translate the Information Given by the Manufacturer?

The provision, including the translation of information given by the manufacturer (IFU, labeling, etc.) and additional information useful for marketing in the Member State in question, is not considered to compromise the conformity of the product.

Despite this, the organization, in addition to complying with Articles 13 or 14, must also fulfill the specific requirements of Article 16.

Is the Medical Device Sold as Part of a Set?

If the device is not placed on the market on its own, as originally intended, but as part of a set (for example, in the most frequent case, packaged with other products for a specific context of use), it is necessary to verify whether the set thus composed constitutes a system or procedure pack under Article 22:

• If each individual component is a CE-marked medical device or a CE-marked IVD, or complies with the regulations applicable to it when used in a medical procedure or its presence within the joint package is otherwise justified, then the organization is assembling a system or procedure pack and must comply with the specific requirements of Article 22.
• If, however, the set includes devices without CE marking, or the chosen combination is not compatible with the original intended purpose of the individual devices, or – where applicable – the set is sterilized and the sterilization has not been carried out according to the manufacturer’s instructions for each constituent element, this is considered a standalone device and the organization assumes the obligations of the manufacturer.