Retail, distribution and importing

The scope of responsibility depends on the role in the supply chain. It is important that you, as an economic operator, understand your role and the responsibility that comes with it.

Roles of responsibility in the supply chain

There are two clear roles in the supply chain between the manufacturer and the end user; these are the importer and the distributor.

The clear differences between them are that:

• an importer buys devices from countries outside the EU/EEA and sells them on the Union market within the EU/EEA, while a
• distributor both buys and sells devices on the Union market.

In the legislation, these roles have legal definitions whose meanings do not always correspond with those that are normally applied commercially.

Responsibility of distributors

A distributor is defined as: ‘a natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service’.

In this regard, ‘market’ refers to the entire market within the EU/EEA, and thus also includes the trading of products across borders within the EU. It is a role which includes many operators, of different types and sizes.

Examples of distributors:

• healthcare wholesalers
• general agents
• national offices for manufacturing groups
• medical supply shops
• pharmacies
• internet shops
• tech shops
• supermarkets
• corner shops
• kiosks.

All distributors essentially have the same role of responsibility, but in practice this places different requirements on the application based on the scope and nature of the business. For example, a kiosk that sells plasters and condoms does not need to have the same system developed in order to fulfil its obligations as a general agent that distributes medical implants. However, it is important to understand that there is no such thing as ‘just selling’ when it comes to medical devices.

A distributor’s general responsibility is statutory and means, inter alia, that a distributor that sells on the Swedish market must:

• verify that the devices have a CE mark
• verify that a document exists with a declaration of conformity from the manufacturer
• verify that the devices have labelling and sufficient instructions for use and that they are in Swedish
• ensure that the devices are transported and stored correctly
• refrain from selling devices that do not comply with the above and inform the manufacturer of such devices
• refrain from selling devices that they know, or suspect, are faulty and inform the manufacturer of such devices
• inform the Medical Products Agency if the distributor knows, or suspects that the device constitutes a serious risk
• receive reports from customers about incidents (and accidents) with the devices and forward them to the manufacturer or their authorised representative and the importer
• receive complaints from customers about the devices and forward them to the manufacturer or their authorised representative and the importer
• monitor complaints, information about faulty devices and information on withdrawals and recalls
• monitor economic operators which have supplied devices and to whom products have been supplied/sold (except to end users that are not healthcare institutions)
• co-operate with the manufacturer or their authorised representative to fix or remove faulty devices
• co-operate with the Medical Products Agency or other competent authorities in order to provide the information, documents and device samples that are requested or to fix or remove dangerous devices.

This list is not exhaustive and does not replace the operators' own obligation to inform themselves of the regulatory framework.

Responsibility of the importer

An importer is defined as: ‘a natural or legal person established within the Union that places a device from a third country on the Union market’.

All economic operators who receive direct deliveries of devices from countries outside the EU/EEA, third countries, are considered to be importers. The role of the importer therefore comprises more economic operators than the general agent for all, or parts of, the EU/EEA or the person who is the authorised representative of the device. The delivery arrangements for the devices can therefore affect what role of responsibility an economic operator has, and consequently the scope of the responsibility.

The responsibility that an importer has compared to a distributor is extensive; you should therefore consider whether you want to take this on.

Importers not only have all the same responsibilities as a distributor, but also a number of additional responsibilities. An importer’s public responsibility is statutory and means that an importer must, inter alia:

• check that there is an authorised representative (EC REP)
• check that the addresses of the manufacturer and authorised representative (EC REP) are stated on the packaging
• state their name and address on the packaging in a way that does not destroy or corrupt the original label — this does not count as a change
• check that the manufacturer has registered the device
• check that the device has been assigned a UDI by the manufacturer
• be able to produce the document with the manufacturer’s declaration of conformity and certificate from a notified body if required for at least ten years after the last import.

This list is not exhaustive and does not replace the importer’s own obligation to inform themselves of the regulatory frameworks.

Informing the Swedish MPA

As mentioned above, when devices made available in Sweden, there are certain situtations where you as a distributor and/or an importer are responsible for informing the Swedish MPA. Please contact the Swedish MPA by e-mail to registrator@lakemedelsverket.se.

The situations where you shall inform the Swedish MPA are:

• suspected or verified serious risks associated with a device
• suspected or verified falsification of a device.

You shall also inform the Swedish when you have the intention to provide a translation or repackaging according to article 16.2-16.4 Please read further in the section on changes to devices below.

When you suspect or can verify a serious risk associated with, or a falsification of, a device, you shall inform the Swedish MPA with the following information. You can find the definition of serious risk in paragraph 18 in the guidance document MDCG 2023-3.

• data to identify the device, such as:
  • name
  • model
  • description of the device
  • UDI, if available
• if the device has been made available on the Swedish market, and if so the amount of devices that has been made available
• manufacturer (name and contact details)
• the serious risk or the falsification/fraud that is identfied or can be suspected
• the correative actions that has been taken
• contact details to the distributor/importer that is informing the Swedish MPA

Changes to devices

As a distributor or importer, you must not make any changes to a device. If you do, then the entire manufacturer’s responsibility will be transferred to the person who makes the change. The manufacturer’s responsibility is very extensive and imposes such demands that it is difficult to manage without specific staff or consultants.

Changes that result in this responsibility are, inter alia:

• putting your own name on the product without this being clearly agreed with the manufacturer and the manufacturer’s information being on the label
• changing the intended purpose of the device, for example marketing the device with new promises. other changes that may affect the device’s compliance with the requirements are also included.

More information is available in Article 16 of the MDR and the IVDR.

Importers and distributors may translate the label, instructions for use and any other information belonging to a medical device. However, extensive requirements must be met.

This includes, inter alia, that:

• operators that translate must have a quality management system that ensures that the translation is correct and up to date
• the quality management system must be certified by a notified body within the relevant field of devices
• operators that translate must state their name, address and what they have done on the label or attached information
• operators that translate must inform the competent authority and manufacturer of what they intend to do and, upon request, present samples of the device
• operators that translate must present the certificate from the notified body to the competent authority.

Repackaging, relabelling or translation of labelling, instructions for use (IFU) or miscellaneous information

Different requirements are applicable depending on the applicable legislation for placing the concerned devices on the market. The economic actor (importer or distributor) who performs activities with repackaging, relabelling or translation of labelling, instructions for use (IFU) or miscellaneous information need to inform themselves on which legislation that was applicable for the devices and act accordingly.

Devices placed on the market according to MDD, IVDD, AIMDD or the transitional provisions

If a device placed on the market according to the national implementation of MDD, IVDD or AIMDD, including those placed on the market according to the transitional provisions in MDR/IVDR (legacy devices), any changes transfer the entire manufacturer’s responsibility to the actor/person who makes the change. The only option to avoid assuming the responsibility of the manufacturer is that the actor/person perform the changes as a subcontractor of the manufacturer within the manufacturer’s quality management system. This arrangement needs to explicitly clear in an agreement between the actor/person and the manufacturer.

Devices placed on the market according to MDR or IVDR

In general, any changes to a device placed on the market according to MDR or IVDR the entire manufacturer’s responsibility will be transferred to the person who makes the change. However, there are possibilities to avoid assuming the responsibility of the manufacturer as described below.

The option to perform the changes as a subcontractor of the manufacturer within the manufacturer’s quality management system is also feasible for devices according to MDR and IVDR. This arrangement needs to explicitly clear in an agreement between the actor/person and the manufacturer.

In MDR and IVDR there is an exception with provisions for distributors and importers to perform some specific changes for devices according to MDR or IVDR without involving the manufacturer. The provisions are limited to repackaging, relabelling and/or translation of the labelling, instructions for use (IFU) or other user information accompanying the device in order to comply with national requirements. The following conditions must be met:

1. the devices shall be fully compliant with MDR or IVDR
2. the actor shall fulfil all requirement in article 16 in MDR or IVDR.

The requirements in arcticle 16 in MDR/IVDR includes inter alia:

• Each single device (specimen) shall be compliant with the requirements in MDR or IVDR. This shall be verified by the EU declaration of conformity (DoC).
• The actor performing the changes shall have its own quality management system (QMS) in place to ensure inter alia, that the translations, altered labelling, and packaging are correct and kept up to date with possible changes by the manufacturer.
• The actor shall involve a notified body that shall assess the QMS and draw up a certificate that the requirements on the QMS is fulfilled.
• The actor that has performed the allowed changes shall include the following information in the labelling or an accompanying document: Name, address and the changes that have been made.
• When all requirements are in place (e.g. the certificate from the notified body), the actor shall register/notify the activities according to article 16. The notification/registration shall be made with the competent authority in the member state(s) where the changed devices are to be made available on the market and at least 28 days prior to selling (making the changed devices available) on the concerned market.
• The certificate issued to the actor, covering the QMS for the activities with changes, shall be submitted with registration. N.B. that it is not appropriate or sufficient to submit the certificate issued to the manufacturer of the devices.
• The actor shall also notify the manufacturer of the changed devices at least 28 days prior to selling (making the changed devices available).

This list is not exhaustive and does not replace the actor’s own obligation to inform themselves of the regulatory frameworks.