EUDAMED: Peran Pendaftaran untuk Importir dan Distributor

EUDAMED is not one form a manufacturer fills in; it is a database with distinct roles, and an importer or distributor sits in a different role than the manufacturer. Confusing the two is a common compliance miss that delays a device from reaching the market. This guide explains who registers what in EUDAMED, which role an importer and a distributor play, and the data that each has to keep up to date.

Set up your EU actor roles through the OEM / ODM localization , with the manufacturer, importer and distributor registrations mapped to your market.

The roles EUDAMED assigns

EU MDR assigns distinct responsibilities to economic operators. The manufacturer registers the device and is responsible for the technical documentation and the declaration of conformity. The authorised representative acts for a manufacturer outside the EU and is the EU-based contact. The importer places a device from a non-EU manufacturer onto the EU market and is recorded as such. The distributor holds the device and makes it available but does not change it. Each role is recorded differently in EUDAMED, and each has its own duties for labelling, traceability and reporting.

What the importer’s role actually covers

An importer is more than a shipper. The importer must verify that the device is CE marked, that the declaration of conformity exists, that the manufacturer has an authorised representative, and that the labelling is in the required language. The importer is also registered as an importer in EUDAMED, has to be identifiable to the authority, and is responsible for the registered place of business being listed correctly. For a first import, the importer has to confirm the device’s UDI and that its own name and address appear on the label with the devices it imports.

What the distributor’s role covers

A distributor holds the device and makes it available but does not place it on the market in the same way an importer does. The distributor’s duty is to keep the traceability, to store and handle the device so it does not lose its conformity, and to report any suspected non-conformity to the manufacturer or importer. In EUDAMED the distributor is registered as a distributor and, crucially, must be able to tell the authority which device and which operator the product came from. The distributor is the link that lets a recall trace back to a batch.

What has to stay current

Registration is not a one-time exercise. The importer and distributor must keep the registered place of business, the contact details and the list of devices they handle up to date, and they are part of the reporting chain when a serious incident occurs. The single registration number, actor ID and the device data all feed the same database, so a change of address or a new product line is a data update, not a new process. The EU medical device database is the authoritative reference for the current structure of these roles; the EUDAMED database page on the European Commission site sets out what each economic operator registers.

Entering the EU market? Send Sanyang your device classification and target member state for an EUDAMED role check.

Bacaan terkait

See the compliance scope on OEM / ODM localization and the product range on produk.

Pertanyaan Umum

Apakah importir mendaftar sebagai produsen di EUDAMED?

Tidak. Seorang importir dicatat sebagai importir, peran yang terpisah dari pabrikan. Importir memverifikasi penandaan CE dan deklarasi kesesuaian tetapi tidak memiliki dokumentasi teknis.

Apakah yang harus didaftarkan oleh distributor UE?

Seorang distributor mendaftar sebagai distributor dan menjaga ketertelusuran serta tautan perangkat-ke-operator sehingga otoritas dapat melacak penarikan kembali ke satu batch, tanpa mengubah perangkat.

Apakah registrasi EUDAMED hanya satu kali?

Tidak. Tempat usaha terdaftar, rincian kontak, dan daftar perangkat yang ditangani harus tetap mutakhir, dan data aktor serta perangkat menjadi masukan untuk rantai pelaporan insiden serius.

Untuk lebih detail, lihat Pelabelan dan Petunjuk Penggunaan.