The import of medical devices in Italy

Importazione di dispositivi medici

The concept of “import” is not precisely straightforward, even if it is considered trivial. Initially “import” meant the transit of products through a country border. However, the concept of “import” considerably narrowed after the deals signed between the Member States inside the European Union.

An importer is “any natural or legal person established within the Union that places a device from a third country on the Union market” in the medical devices field. Therefore the medical devices are imported in Italy only when they come from countries located outside the European Union.

The medical devices undergo vigilance activities, performed by the “Uffici di Sanità Marittima, Aerea e di Frontiera” (USMAF-SASN and relevant territorial units) of the Italian Ministry of Health if they are imported from a third country, since they are goods of health interest.

The request can be made by the importers or by their legal representatives. The assessment made in the customs concerns the medical devices accompanying documents, the identity and the materials, if the evaluation is deemed necessary to verify that national and European requirements are met by the medical devices under assessment.

Evaluation of medical devices

The medical devices are assessed in order to evaluate the compliance of the information reported in the labelling, in the Instructions for Use and in the Declaration of Conformity. An example of documentary evaluation is based on the check of the accompanying documents, which must correspond to the ones previously uploaded in the database of the Ministry of Health when the medical devices were registered.

The language used in the information provided to the user is also subject to assessment. The labelling and the instructions for use must be necessarily written in Italian in order to import the medical devices in Italy. The procedure is the same for all the classes of medical devices; if the medical devices were object of procedures of conformity assessment involving a Notified Body, the relevant certificate of conformity must be attached to the import request.

Medical Device Custom

If the customs office observed non-conformity in the medical devices under assessment, therefore it would contact the importer (or its legal representative) in order to receive clarifications or supplementation to the previous request.

In case of success, the assessment of the customs office ends with the final release of an acceptance provision for the import, which is the “Nulla Osta Sanitario – NOS” for medical devices; the NOS is indispensable for the transit and the carriage of goods of health interest. In case of failure in passing the assessment, the customs office release a non-acceptance provision for the import.

The timeframe for the release of the “Nulla Osta Sanitario” is defined in the “Decreto del Presidente del Consiglio dei Ministri del 04 Novembre 2010, n.242”. The indicated time limit for the documentary assessment is 8 hours, whereas the indicated time limit for the physical inspection of goods is 72 hours.

After the outbreak of the COVID-19 pandemic the Italian Government adopted several provisions in order to ease the import of products, including some medical devices, intended to fight the pandemic.

These provisions included faster procedure of customs clearance of devices necessary to fight the pandemic and dispensation on some requirements, such as the obligation of providing the information in Italian language. However the European Union published the “Raccomandazione (UE) 2021/1433 del 1 settembre 2021”, in which the European Commission encourages the vigilance authorities to stop the making available of the medical device when they do not meet the requirements of the Regulation (EU) 2017/745 and following amendments, concerning the medical devices.

Written by: Daniele Scarpino