European Union · Medical Devices

EU In Vitro Diagnostic Regulation Compliance

A practical guide to EU In Vitro Diagnostic Regulation Compliance for medical devices sold in the European Union: who it applies to, what to prepare, and the mistakes that cause rejection.

Who needs it

In vitro diagnostic medical devices and accessories; Laboratory reagents, analysers, and specimen collection products

Authority

EU national competent authorities and notified bodies

Legal basis

Regulation (EU) 2017/746 (IVDR)

Local representative

An EU authorised representative is required for non-EU manufacturers

Timeline

Often many months, depending on class and notified body capacity

Cost

Notified body, performance evaluation, and QMS costs vary widely

If you do not comply

Withdrawal, fines, and liability

Who needs this

In vitro diagnostic medical devices and accessories
Laboratory reagents, analysers, and specimen collection products

Documents you need

Technical documentation and performance evaluation
Notified body certificate where applicable
Quality management system evidence
Declaration of conformity and UDI data

Compliance checklist

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

Technical documentation and performance evaluation
Notified body certificate where applicable
Quality management system evidence
Declaration of conformity and UDI data

How to comply

Classify the device under the IVDR
Prepare performance evaluation and scientific validity evidence
Implement the quality management system
Obtain notified body certification and register

Brief for your lab or agent

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

Request: EU In Vitro Diagnostic Regulation Compliance — European Union
Product category: Medical Devices
Authority: EU national competent authorities and notified bodies
Legal basis: Regulation (EU) 2017/746 (IVDR)

Documents we already have:
  1. Technical documentation and performance evaluation
  2. Notified body certificate where applicable
  3. Quality management system evidence
  4. Declaration of conformity and UDI data

Questions:
  1. Does our product fall under EU In Vitro Diagnostic Regulation Compliance 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

Often many months, depending on class and notified body capacity.

Notified body, performance evaluation, and QMS costs vary widely.

Common rejection reasons

Class assigned incorrectly
Performance evaluation incomplete
Post-market surveillance plan missing

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.