In addition to obligations of manufacturers, the European Union (EU) medical device regulation (Regulation (EU) 2017/745, MDR) and in vitro diagnostic (IVD) regulation (Regulation (EU) 2017/746, IVDR) also include obligations of importers and distributors of devices.
Importers are any natural or legal persons established within the EU that place a device from a third country on the EU market when the device doesn’t have a legal manufacturer established within the EU, while distributors are any natural or legal persons in the supply chain, other than the manufacturer or the importer, that make an unused device available on the EU market.
The supply chain of devices is described in the below diagrams. A manufacturer outside the EU needs to appoint an authorised representative to represent them in the EU. For devices with a legal manufacturer outside the EU, an importer in the EU places the devices on the market. The importer can themselves make the devices available to users, or the importer can supply the devices to distributor(s) who make the devices available to users. If the legal manufacturer is in the EU, the manufacturer places the devices on the market, and can themselves make the devices available to users, or supply the devices to distributor(s) who make the devices available to users.
To legally import or distribute medical devices or IVD devices on the EU market, importers and distributors need to follow the obligations described in the MDR and IVDR. This blog post describes these obligations, including the requirements for device labelling and marketing materials.
Obligations of MD and IVD importers and distributors
Ensuring conformity with MDR and IVDR
Only devices that are in conformity with the MDR or IVDR can be legally imported or distributed on the EU market. Importers and distributors need to verify that the device has been CE marked according to the regulations and that the EU declaration of conformity of the device has been drawn up according to the regulations before making the device available on the market. For imported devices, importers are responsible for identifying the manufacturer of the device and verifying that an authorised representative has been designated for the device by the manufacturer.
Importers or distributors are not allowed to make a device available on the market if they suspect that the device is not in conformity with the regulations. Importers and distributors who suspect that a device which they have made available on the market is not in conformity with the regulations need to immediately inform the manufacturer and, where applicable, the authorised representative and importer. Importers and distributors shall co-operate with the manufacturer and, where applicable, the manufacturer’s authorised representative and the importer, as well as the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with the MDR or IVDR for the device in question, giving details of the non-compliance and of any corrective action taken.
Where the importer or distributor suspects that the device presents a serious risk or is a falsified device, they also need to inform the competent authority of the Member State in which they are established.
Importers need to keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificates, including any amendments and supplements, for at least 10 years, or 15 years in case of implantable devices, after the last device covered by the EU declaration of conformity has been placed on the market.
Distributors are obligated to, 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 they have made available on the market.
Importers and distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have made available on the market. Importers and distributors, upon request by a competent authority, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.
Device labelling and marketing materials
According to the MDR and IVDR, importers and distributors have the obligations to verify that the device is labelled in accordance with the regulations and is accompanied by the required instructions for use. They also need to verify that a Unique Device Identifier (UDI) has been assigned for the device by the manufacturer where applicable.
Importers are also responsible for indicating their information on the device or on its packaging or in a document accompanying the device, and distributors of imported devices need to verify that the information of the importer is accompanying the device.
When verifying that the labelling and instructions for use comply with the regulations, national language requirements need to be considered.
If importers or distributors use their own marketing materials in advertising the devices they make available on the market, they are also responsible for making sure that the marketing materials comply with the regulations. It is prohibited to use text, names, trademarks, pictures and figurative or other signs in the marketing materials that may mislead the user or the patient about the device’s intended purpose, safety and performance. Possible additional national requirements for advertising and marketing also need to be considered when designing the marketing materials.
Storage and transport conditions
While a device is under the responsibility of an importer or distributor, the importer or distributor needs to ensure that the storage or transport conditions comply with the conditions set by the manufacturer.
Device and operator registration requirements
Importers are obliged to verify that the device being placed on the market is registered in the electronic system (EUDAMED) and to add their details to the registration by linking themselves to the manufacturer whose medical devices they import in the EUDAMED Actor module. However, as use of the EUDAMED actor module is not mandatory yet, importers need to follow national registration requirements. There also might be national registration requirements for distributors, although distributors are not required to register to EUDAMED according to the MDR and IVRD.
Register of device complaints
Importers and distributors need to keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer and other applicable economic operators with any information requested by them, in order to allow them to investigate complaints.
Additionally, importers and distributors who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have made available on the market shall immediately forward this information to the manufacturer and, where applicable, the authorised representative and importer.
Device identification within the supply chain
Importers and distributors are obliged to co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices. Importers and distributors need to be able to identify (1) any economic operator to whom they have directly supplied a device, (2) any economic operator who has directly supplied them with a device, and (3) any health institution or healthcare professional to which they have directly supplied a device to the competent authority, for a period of at least 10 years, or, in the case of implantable devices, for a period of at least 15 years after the last device covered by the EU declaration of conformity has been placed on the market.
Cases in which obligations of manufacturers apply to MD and IVD importers or distributors
An importer or distributor will acquire the obligations of manufacturers if it:
- makes available on the market a device under its name, registered trade name or registered trademark. However, this doesn’t apply to 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 the regulations.
- 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. This does not apply to a person who is not considered a manufacturer who assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
However, the importer or distributor will not receive the obligations of a manufacturer if they make the following changes to a device already placed on the market:
- translation of the labelling and instructions for use or including further information which is necessary in order to market the device in the relevant Member State.
- changes to the outer packaging, including a change of pack size, if the repackaging is necessary in order to market the device in the relevant Member State and if it is carried out in such conditions that the original condition of the device cannot be affected by it. Sterile devices cannot be repackaged as the original condition of the device can be adversely affected if the packaging that is necessary for maintaining the sterile condition is opened, damaged or otherwise negatively affected by the repackaging.
A distributor or importer that relabels or repackages devices shall indicate on the device or, where that is impracticable, on its packaging or in a document accompanying the device, the activity carried out together with its information.
Distributors and importers who relabel or repackage devices need to have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date, and that the relabelling or repackaging is performed by a means and under conditions that preserve the original condition of the device and that the packaging of the repackaged device is not defective, of poor quality or untidy. The quality management system shall cover also procedures ensuring that the distributor or importer is informed of any corrective action taken by the manufacturer in relation to the device in question in order to respond to safety issues or to bring it into conformity with the regulations.
At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of these activities need to inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to the relabelling or repackaging, attesting that the quality management system of the distributer or importer complies with the requirements.
Services offered by Medfiles for importers and distributors of medical devices and IVD devices
As described in this blog, importers and distributors need to consider the requirements in the MDR and IVDR and any applicable national requirements carefully before making medical devices or IVD devices available on the market. The main requirements for medical device importers and distributors in the EU regulations are described in MDR and IVDR articles 7, 13, 14, and 16 as well as Article 25 in the MDR/Article 22 in the IVDR. If your organisation needs any help in navigating in the complex regulatory environment, don’t hesitate to contact Medfiles’ Medical Device and IVD experts, who can help in all matters regarding importing and distribution of devices, from gap analysis and general consultation to translating labelling and instructions for use, and reviewing marketing materials.
BLOG: What to know about medical device and IVD class changes and transition periods?
The MDR and IVDR have overhauled the classification system for medical devices and in vitro diagnostic devices, aiming to better align regulatory requirements with technological advancements and patient safety considerations.
For manufacturers, this means a comprehensive reassessment of their product portfolios. Devices previously categorised as lower risk under the previous directives might find themselves reclassified under MDR and IVDR.
