Importers: What Do the MDR and IVDR Actually Demand?

An importer generally buys a medical device from a manufacturer (outside the EU) and sells it either to a distributor or an end user. In the case of direct sales, distributors who purchase medical devices outside the EU become importers.

e) Essential and non-essential factors

It is essential that:

• The importer is based within the EU
• A transfer or rights takes place (between the importer and another natural or legal person) based on an offer or an agreement

In contrast, it does not matter whether:

• The agreement is made in writing or orally
• A payment is made for the transfer of ownership or it is done free of charge
• A transfer of ownership takes place. Also possible is the transfer of possession or any other rights (except intellectual property rights) ,e.g., by way of loan

f) What is not classed as an import?

The Blue Guide gives some examples of what is not classed as an import:

• A consumer buys a device outside the EU and brings it into the EU for their “personal use”
• A manufacturer based in the EU produces a device outside the EU but under its own QM system and then brings this device into the EU
• A device is brought into the EU for testing (verification, validation)
• A device is brought into the EU for a trade fair or exhibition. This requires the device to be labeled accordingly

2. What do the MDR and IVDR require from importers?

a) Registration in EUDAMED

Before importers import devices, they must register in EUDAMED. This requirement is established in Article 30 and Article 31 as well as Annex VI of the MDR. The requirements of the IVDR are identical.

Entries are publicly accessible and must be updated as required and confirmed every two years.

b) Their name on the device labeling

Article 13 of the MDR requires importers to “indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established”.

c) An inspection of the devices

The MDR and the IVDR require importers to inspect the devices to ensure:

• The device has been CE marked
• A declaration of conformity has been drawn up
• An authorized representative has been named
• The device is labeled in accordance with the MDR/IVDR
• Instructions for use (as required) are provided with the device
• The device has been assigned a UDI

However, there is no general testing obligation. So, importers do not have to test the medical devices.

It is currently being disputed whether the importer must carry out a complete inspection of the above aspects. Unlike for distributors, the MDR does not establish any exemptions (e.g., sampling). However, based on the Blue Guide, we assume that a complete inspection is not what is intended.

d) To contribute to the communication between manufacturers, users and authorities

Importers are an essential node in the communication between manufacturers, users and authorities. They must help ensure that all information required to ensure patient safety and that action can be taken quickly in the event of risks is available to these groups:

• Inform the manufacturer or its authorized representative if it considers or has reason to believe that the device does not comply with the MDR (Article 13(1) and Article 13(7)).
• Inform the authorities in the event of serious risks (Article 13(2))
• Provide the manufacturer, authorized representative and distributors with customer complaints (Article 13(6) and Article 13(8))

e) Transition periods

The MDCG clarifies in MDCG 2021-25 that economic operators must also comply with their obligations under MDR for legacy devices (Article 120, valid MDD certificate). For each economic operator, the MDCG lists the relevant articles of the MDR that they must comply with. For importers, these are the requirements of Article 13:

• Article 13(2) last paragraph: This deals with the information requirements in the context of post-market surveillance.
• Article 13(4): Importers shall verify that the product is registered in EUDAMED.
• Article 13(6): Importers shall keep a register of complaints.
• Article 13(7): This also deals with the information obligations and cooperation in corrective actions.
• Article 13(8): This also deals with information obligations and cooperation in corrective measures.
• Article 13(10): This paragraph concerns the cooperation of manufacturers with the authorities.

3. What importers should do now

a) Use our checklist

Importers should go through the Johner Institute's checklist for importers. It makes it quick and easy to check conformity with the MDR and/or IVDR requirements and to correct any potential deviations. This provides legal certainty and will ensure you avoid sanctions from authorities and courts.