Importing Medical Devices for COVID-19

Many companies are dealing with the importation of medical devices from non-EU countries – China in particular – to address the COVID-19 emergency. Below are the aspects to consider and requirements to fulfill for importation.

The scenario considered is that of a company intending to import into Italy medical devices legally CE marked by a non-EU manufacturer, during a period when Directive 93/42/EEC is still in force.

Notification in the Ministry of Health Database

Medical devices must be notified in the Ministry of Health database. This activity can be done by the manufacturer, their authorized representative, or a person delegated by the manufacturer (for example, the importer).
Previously, other delegated parties may have already registered the device. Therefore, before proceeding, it is necessary to verify the absence of existing registrations for the same medical device.

Once the absence of previous notifications has been established, to notify the medical device in the Database, it will be necessary to send to the Ministry of Health via certified email (PEC) a specific delegation form completed by both the non-EU manufacturer and the importer using the Ministry’s template.

After sending, you will not receive a response from the Ministry, but you will be able to notify the medical device immediately.

Manual and Labeling in Italian

Medical devices sold in Italy must be accompanied by user manuals and labeling in Italian. The translation can be done by the importer provided that the manufacturer authorizes it, defining any requirements for the approval of the translated documentation.

Furthermore, to avoid problems at customs, before importing, it is important to verify that the labeling does not have any printing issues. This is particularly important for the CE mark.

Importer’s Duties

The new Medical Device Regulation (MDR) 2017/745 prescribes specific duties for distributors and importers. The Directive 93/42/EEC, which is effectively still in force given the postponement of the regulation due to COVID-19, is not as explicit.

Despite this, there are aspects that the importer is required to manage.

Traceability

It is sufficient to maintain a register correlating the s/n (or batch number) of the medical devices sold with the customer data. It may not always be possible to reach the end-user, but it is advisable to go as deep as possible into the distribution chain. This duty should also be extended to sub-distributors.

Adverse Events, Complaints, Defects

An importer who becomes aware of adverse events, complaints, defects, and in general problems related to the medical device, must immediately communicate this to the manufacturer or their authorized representative in Europe.
Nothing more, but it is essential that the communication is made without delay.

Technical assistance and repair activities, unless authorized by the manufacturer, cannot be carried out by the importer.

If You Need Help

We are receiving many requests during this period, and there are many variables not considered in this article. If you need specific support for importing medical devices related to the COVID-19 situation into Italy, you can contact us, we are fully operational.