Acting as a distributor
What we can do for your business at European Community (EC), if you are looking for an importer?
For the first time, the MDR defines general obligations for various economic operators within the medical devices industry, including distributors. As a result, distributors are subject to their own set of duties and face specific liability risks if those duties are breached.
What is a distributor: any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a device available on the market up until the point of putting into service.
What means making available on the market? Any supply of a device, other than an investigational
device, for distribution, consumption or use on the Union market in the course of commercial activity, whether in return for payment or free of charge.
What means placing on the market? The first making available of a device, other than an investigational device, on the Union market.
What means putting into service? the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.
Before selling:
When making a device available on the market, distributors shall, in the context of their activities, act with due care in relation to the requirements applicable.
Before making a device available on the market, distributors shall verify that all the following requirements are met:
a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
b) the device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10;
c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
d) that, where applicable, a UDI has been assigned by the manufacturer.
In order to meet the requirements referred to in points (a), and (b) and (d) of the first subparagraph the distributor may apply a sampling method representative of devices supplied by that distributor.
Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which it is established.
Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer
and, where applicable, the manufacturer's authorised representative and the importer.
Into the market:
Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative,
and the importer. They shall keep a register of complaints, of nonconforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative
and the importer informed of such monitoring and provide them with any information upon their request.
Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.
Acting as a importer
What we can do for your business at European Community (EC), if you are looking for an importer?
For the first time, the MDR 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.
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.
Labelling 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.
Other Obligations
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 attention to this point when formulating contractual agreements with manufacturers.