Import & Export
Fast and smooth import and export of medical devices
The European Medical Device Regulation (EU-MDR) defines for the European countries general obligations of the various national and international economic partners within the medical technology industry. Importers are also subject to their own obligations and thus also to certain liability risks.
The US market is regulated by the FDA Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA’s Center for Devices and Radiological Health (CDRH) is responsible for overseeing the medical device program. An importer must comply with Title 21 Code of Federal Regulations (21 CFR) Part 807.3(g). In perticular the importer has to fulfill the Medical Device Reporting (MDR) (21 CFR 803), Reports of Corrections and Removals (21 CFR 806), and the Medical Device Tracking (21 CFR 821). All medical devices imported into the United States (U.S.) must meet the regulatory requirements of both the U.S. Bureau of Customs and Border Protection (CBP) and FDA.
The Center for Devices and Radiological Health (CDRH) is responsible for issuing export certificates for medical devices such as Certificate to Foreign Government (CFG), Certificate of Exportability Under Section 801(e)(1) of the Federal Food, Drug, & Cosmetic Act (FD&C Act), Certificate for Exportability Under Section 802 of the FD&C Act, and Non-Clinical Research Use Only (NCR).
Import of medical devices
In Europe, according to Article 2 MDR, the term importer means any natural or legal person established in the European Union who places a product from a third country on the Union market. Third countries such as Switzerland are also treated under the MDR through trade agreements (Mutual Recognition Agreement MRA).
The obligations of importers are regulated in Article 13 MDR. Importers may place only medical devices that are MDR-compliant on the market in the EU. It is the importer’s responsibility to check the respective products for the presence of a CE marking and an EU declaration of conformity. The medical devices must also be correctly labeled and have MDR-compliant instructions for use and a Unique Device Identification Number (UDI). The importer must know the manufacturer of the devices and its authorized representative (EC Rep).
Importers are further obligated to support the competent authorities in confirming the safety of the medical devices; e.g., importers must be able to provide free samples of the medical device to a competent authority. They should consider this when negotiating a contract with the manufacturer.
Importers must provide specific information on the devices they place on the EU market or on their packaging: their name, registered trade name, trademark and registered place of business, and address.
Importers must ensure that medical devices are registered in the electronic system referred to in Article 29 MDR and Article 31 MDR (EUDAMED database). Importers must also maintain a register of complaints.
In some individual cases, importers may have the obligations of a manufacturer, according to Article 16 MDR (for example, when there is a change of the intended purpose of a device already on the market).
Importers must perform compliant repackaging, have their own quality management system in place to ensure that the original condition of the product is maintained, and ensure that the packaging of the repackaged medical device is not defective.
Export of medical devices
When exported, medical devices within Europe do not have to go through regulatory approval procedures to be sold. For exportsoutside of Europe, on the other hand, the respective legal regulations of the country of destination apply. These regulations must be checked before each export, considering the individual case. In order to facilitate the export of medical devices, manufacturers can request a so-called export certificate, depending on the requirements of the respective country regulations according to § 34 Medical Devices Act or § 10 Medical Devices Implementation Act. The certificate confirms the marketability of the medical device in Germany and is issued by the responsible regulatory authority at the state level.
We are happy to help you with the import and export of medical devices in compliance with relevant regulations and requirements. Just contact us!