MDR: new duties for importers of medical devices
For the first time, the MDR (PDF) defines general obligations for various economic operators within the medical devices industry, including importers. As a result, importers are expressly subject to their own set of duties and face specific liability risks if those duties are breached. In some cases, manufacturers' obligations may apply for importers as well.
Pursuant to Article 2 of the MDR, an "importer" is any natural or legal person established within the Union that places a device from a third country on the Union market. Depending on whether the Mutual Recognition Agreement (MRA) currently being negotiated between the EU and Switzerland is signed or not, and whether or not an agreement is reached with the United Kingdom upon expiration of the "Brexit" transitional period, Switzerland and the United Kingdom will also have to be treated as "third countries" in terms of the MDR.
General Obligations of Importers (Article 13 of the MDR)
The obligations for importers are specified in Article 13 of the MDR. They relate both to product conformity in the narrow sense and to interactions between importers and other economic operators, such as manufacturers, their authorized representatives and the competent supervisory authorities.
Verification and Cooperative Duties
Importers may not place devices on the EU market unless those devices comply with the MDR. Accordingly, they are required to verify that the relevant devices have a CE marking and an EU declaration of conformity. They are also required to verify that the devices are labelled correctly, that their instructions for use conform to the MDR's requirements and that they have a Unique Device Identification Number ("UDI"). Importers also must be able to identify the device's manufacturer and the latter's authorized representative (EC Rep).
If an importer has reason to believe that a device fails to meet the MDR's requirements, it may not place that device on the market until the device has been brought into conformity with the Regulation. In such a case, the importer is required to notify the manufacturer and its authorized representative.
Importers are also required to cooperate with the competent authorities, at the latter's request, in any action taken to eliminate or, if that is not possible, to mitigate risks associated with devices which they have placed on the market. This could extend as far as providing the competent authority with samples of the device free of charge or granting the authority access to the device. This aspect should be considered when negotiating contractual agreements with the manufacturer. Depending on the price of the device, the obligation for importers to provide the authorities with a "sample" free of charge could be financially significant.
Labeling and Registration Obligations
Importers are required to provide information on devices marketed in the EU, on their packaging or on an accompanying document, about their name, their registered trade name/trademark (if applicable), their registered place of business and the address at which they can be reached. In doing so, they must ensure that any additional label does not obscure the information on the label placed by the manufacturer.
Importers are also required to verify that the device is registered in the electronic system pursuant to Article 29 of the MDR and they are to add their data pursuant to Article 31 of the MDR to this registration. Of course, these obligations apply only if the EUDAMED database is functioning.
The above list is not exhaustive. It does not include additional statutory duties in connection with the storage and shipment of devices, the duty to keep a register of complaints and special documentation requirements.
Importers cannot do all this unless the manufacturers enable them to do so by supplying importers with the necessary documents and information. Importers should pay particular attention to this point when formulating contractual agreements with manufacturers.
The Importer as Manufacturer (Article 16 of the MDR)
The manufacturer's obligations may fall to the importer in individual cases. In accordance with Article 16 of the MDR, this is the case if the importer does any of the following:
- makes available on the market a device under its name, registered trade name or registered trademark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
- changes the intended purpose of a device already placed on the market or put into service;
- •modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
Changes to the outer packaging of a device which has already been placed on the market, including changes in pack size, do not make the importer into a manufacturer, provided the repackaging is necessary in order to market the device in the relevant member state and provided that this is done under conditions which ensure that the original condition of the device cannot be affected. In case of devices which are placed on the market in sterile condition, the original condition of the packaging is considered to be adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise adversely affected by the repackaging. Importers which are planning to repackage devices must have a quality management system of their own which ensures that the original condition of the device is preserved and that the packaging of the repackaged device is not defective, of poor quality or untidy.
A wide variety of new statutory obligations will apply for importers once the MDR enters into effect. In certain cases, they may even assume the role of manufacturer. Importers must be aware of this so that they can take the necessary measures to duly comply with these obligations. If importers fail to do so, they may be exposed to far-reaching liability risks in the future due to their failure to comply with the MDR.