EU MDR 2017/745 Explained: Common Questions from Importers and Resellers

If you're bringing medical devices into the EU, here are answers to the questions importers and resellers ask most about [EU MDR 2017/745](/regulations/eu-mdr-2017-745).

What is EU MDR 2017/745?

EU MDR 2017/745 is the regulation governing medical devices sold within the European Union. It sets out the documentation, evaluation, and registration requirements a device must meet before it can be placed on the EU market.

Who does EU MDR 2017/745 apply to?

It applies to manufacturers, importers, and resellers involved in getting medical devices into the EU market. If you are importing or reselling a medical device under your own name or brand, EU MDR 2017/745 requirements extend to you, not just the original manufacturer.

What documentation do I need to show compliance?

You need a CE Certificate issued under MDR 2017/745, along with Technical Documentation describing the device. A Clinical Evaluation Report and a Post-Market Clinical Follow-up Plan are also required to demonstrate the device's safety and performance over time.

What is EUDAMED and why does it matter?

EUDAMED is the EU's registration system for medical devices and the organizations placing them on the market. Registration in EUDAMED is a requirement under EU MDR 2017/745 compliance, alongside your other documentation.

What is UDI assignment?

UDI stands for Unique Device Identification. Each device covered under EU MDR 2017/745 must be assigned a UDI, which is used for identification and traceability purposes across the device's documentation and registration records.

Do resellers need their own CE Certificate?

Resellers should confirm that a valid CE Certificate under MDR 2017/745 exists for the device they are distributing, along with the full supporting documentation set. Keeping copies of this documentation as part of your [supplier compliance](/supplier-compliance) records helps you respond quickly if a customs authority or market surveillance body asks for proof.

What documents should I ask my supplier for?

Request the CE Certificate under MDR 2017/745, the Technical Documentation, the Clinical Evaluation Report, the Post-Market Clinical Follow-up Plan, proof of EUDAMED registration, and confirmation of UDI assignment. Having all six on file before you import reduces the risk of delays or disputes later.

If you want help keeping track of these documents across your suppliers and products, Complyra is worth a look.