Manufacturers must meet specific regulatory requirements under the MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostic Medical Device Regulation) when importing medical devices. In particular, manufacturers are required to prepare the technical documentation and carry out a conformity assessment procedure, often in cooperation with a so-called Notified Body.

For the actual import process, manufacturers and importers must, in addition to MDR & requirements for import, also comply with customs regulations to ensure a successful market entry. This is because both when importing into the European market and exporting to foreign markets, the correct tariff classification of the product is essential. Through tariff classification, the manufacturer assigns the medical device a specific customs tariff number from the European Customs Tariff (TARIC / Combined Nomenclature).

At present, most imports of medical devices into the EU are duty-free. However, certain raw materials used in the manufacture of medical technology are subject to customs duties. The customs tariff number, together with a product description, must be provided in every customs declaration. Without this information, neither import nor export is possible.

At the time of the customs declaration, all required documents must be in the possession of the declarant and available for presentation to the customs authorities. This means that the manufacturer or importer does not have to submit these documents automatically with the customs declaration. However, if the customs authority requests them, they must be provided immediately. Therefore, if a freight forwarder or customs agent is entrusted with customs clearance, it must be ensured that they have access to all required documentation. Any delays are the responsibility of the manufacturer or importer.

But what are these required documents?

Firstly, they include the market access documents. Due to the MDR and IVDR, medical devices are subject to certain restrictions, such as CE marking. Medical devices can only be imported if they meet the requirements of the MDR and IVDR. For this reason, the CE marking and EU Declaration of Conformity—as proof of compliance with the essential safety and performance requirements—and the complete technical documentation are among the mandatory import documents.

Further documents required for customs clearance include:

• Commercial invoice
• Packing list
• Transport document, e.g. CMR consignment note (depending on the mode of transport)

The medical device itself must also meet certain requirements. These include the CE marking of the product as proof of EU conformity and the instructions for use, which must meet specific criteria. If the medical device contains batteries, packaging and transport regulations under dangerous goods law (such as ADR or IMDG Code) must also be observed.