European Union · Medical Devices

EU MDR UDI and EUDAMED

A practical guide to EU MDR UDI and EUDAMED for medical devices sold in the European Union: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

Medical devices placed on the EU market; Manufacturers and authorised representatives

Authority

Notified bodies and EUDAMED

Legal basis

Regulation (EU) 2017/745, Articles 27-29

Local representative

An EU authorised representative is required for non-EU manufacturers

Timeline

Before market placement; EUDAMED modules phase in over time

Cost

UDI and registration costs vary

If you do not comply

Non-compliant device and market restrictions

Who needs this

Medical devices placed on the EU market
Manufacturers and authorised representatives

Documents you need

UDI-DI assignment
EUDAMED registration
Label with UDI

Compliance checklist

Tick each item as you collect it. Saved in this browser only.

UDI-DI assignment
EUDAMED registration
Label with UDI

How to comply

Assign the UDI
Register the device in EUDAMED
Apply the UDI to the label

Brief for your lab or agent

Copy this into an email, then edit the product and channel.

Request: EU MDR UDI and EUDAMED — European Union
Product category: Medical Devices
Authority: Notified bodies and EUDAMED
Legal basis: Regulation (EU) 2017/745, Articles 27-29

Documents we already have:
  1. UDI-DI assignment
  2. EUDAMED registration
  3. Label with UDI

Questions:
  1. Does our product fall under EU MDR UDI and EUDAMED in the European Union?
  2. Which test standards or evidence do you accept?
  3. What is the current fee and lead time?
  4. Is a local representative required, and can you act as one?

Cost and timeline

Before market placement; EUDAMED modules phase in over time.

UDI and registration costs vary.

Common rejection reasons

Missing UDI
EUDAMED record incomplete
Label does not match the registration

Registration, notification, or certification is not the same as approval. Keep the technical file current and make sure the label, listing, and submitted data match.