Obligations of Importers and Distributors According to MDR

The Regulation considers distributors and importers as active parts of the supply chain for a compliant medical device.

It’s not about verifying the proper functioning of marketed medical devices, but rather setting up a system to prevent counterfeiting, improper marking, and the placing on the market of products not properly CE marked or not compliant with European and national legislation.

In the above situations, distributors and importers can be held responsible, along with the manufacturer.

To complete, this is not an absolute novelty. Although Directive 93/42/EEC does not refer to these two figures, the importer’s responsibilities were and are (as it is still in force) subject to Directive 85/374/EEC concerning liability for defective products.

General Obligations of Importers and Distributors

The general obligations of importers and distributors are addressed in Articles 13 and 14 of the MDR, respectively. A good interpretation of these suggests that the two figures should, in summary, carry out the following activities:

1. Two verification phases (in compliance with the regulation and national legislation): prior to purchase and before marketing;
2. Maintaining declarations of conformity and a register of complaints;
3. Proper handling and storage in accordance with the manufacturer’s specifications;
4. Managing communications in case of reports, complaints, non-compliant or counterfeit devices.

It is evident that, to protect the organization, the fulfillment of the above must be demonstrated by implementing a repeatable process and maintaining the related records.

These are clearly additional activities that will require time and, certainly, specific knowledge of the devices involved and the Regulation. Given the potential criticality, the suggestion is to rely on Sistemir to complement the required skills.

The positive aspect is that, in the future, the required verifications will be facilitated by Eudamed, which will allow, through a search starting from the device’s UDI, to obtain a good part of the information.

Translation and Repackaging

There is an article in the regulation that addresses, while keeping the title unchanged, a topic and its exact opposite.

Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons” deals, in the second paragraph, with cases in which the obligations of manufacturers DO NOT apply to importers, distributors or other persons. In these cases, however, additional obligations still apply.

Definitely unclear. Let’s clarify it.

The two activities that can be traced back to the second part of the cited article are:

1. The translation of labeling and/or instructions for use into the language of the country of marketing (an activity that the regulation calls, in a not very intuitive way, relabeling);
2. Changes to the outer packaging of a device already placed on the market. Usually the breakdown into smaller quantities of larger packages (repackaging).

There are many distributors and especially importers who carry out these activities.

The two figures, where they perform at least one of the above activities, must:

1. Indicate on the device or in a document accompanying the device, the activity carried out along with their references;
2. Have a certified quality management system by a body that is notified for the type of devices subject to the activities;
3. At least 28 days before placing the relabeled or repackaged device on the market, inform the manufacturer and the competent authority of the Member State, provide a copy of the aforementioned certificate and, upon request, a sample.

All of the above is covered in the MDCG 2021-26 guideline.

How to Manage Additional Requirements for those who Perform Relabeling or Repackaging

The stringent requirements stem from the fact that repackaging and relabeling are, in fact, activities generally in charge of the manufacturer alone. This doesn’t prevent the activity from being carried out, physically, by the distributor/importer, while leaving the responsibility to the manufacturer.

First example. The distributor/importer translates – because they are native speakers in the country of marketing – the instructions for use, delivers the translation to the manufacturer who will integrate it into the devices destined for that nation in the next shipment.

Second example. The distributor/importer repackages packages of 100 pieces (not yet placed on the market) into two smaller packages of 50 pieces, but acts as an outsourcer for the manufacturer. The latter, required to declare it to their notified body, will maintain responsibility for the activity carried out.

In both examples, the obligations related to repackaging and relabeling activities do not apply to the distributor/importer.