Legacy Device Manufacturers Must Specify an EU Importer and Meet These Specific Requirements
According to the guidance, the designated “importer” of a legacy device (those that continue to be placed on the European market) must comply with certain provisions of EU MDR Article 13. The term “importer” is confusing to many because it sounds as if role is focused on logistics and product handling. It is not. The importer is a compliance role similar to the EU Authorized Representative. How it works.
As you can see below, some of the MDR language in Article 13 is written assuming that the manufacturer will act as their own importer. However, since many non-EU medical device manufacturers do not have legal entity registered in an EU country, a third-party importer is required. These sections of Article 13 apply to manufacturers of legacy devices.
Article 13(3) – Indicate your importer on your labeling
“Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trademark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.”
Article 13(6) – Maintain a complaint and non-conformance log
“Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.”
Article 13(7) – Report non-conforming devices
“Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer’s authorised representative and 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 Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.”
Article 13(8) – Pass along complaints immediately
“Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.”
Article 13(10) – Cooperate with national competent authorities as needed
“Importers shall cooperate with competent authorities, at the latters’ request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.”
What Happens if You Don’t Appoint an EU Importer?
Are you going to prison? No, but if you are exporting to Europe, there’s a reasonable chance that your shipment might be held up at Customs when they do not see an importer listed on your Declaration of Conformity or product labeling. We’ve written an entire blog post on this topic here. Here are some additional questions manufacturers often ask.
Does our EU importer need to take physical possession of our medical devices?
Where do we need to identify EU importer on medical device labeling?
Can we appoint our EU medical device distributor as our importer?
How do the responsibilities of the EU Importer differ from the EU Authorized Representative?
Next Steps
If you are a manufacturer holding legacy MDD CE certificates and you continue to sell those products in the European Union, it is essential that you appoint an importer immediately. MedEnvoy is Europe’s leading independent importer and we can assist you in meeting importer regulations in the EU, UK, and Switzerland.
