Blog Pricing Sign in

© 2026 Made In Tracker

Explore

Companies Devices Documents Persons

Resources

Blog FAQ Glossary About Features

Company

Pricing Partners Refer & earn Top referrers Contact

Legal

Privacy Policy Legal Notice

Ecosystem

Made In Tracker (opens in new tab)EasyUDI (opens in new tab)

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Monthly EUDAMED change digest

Get a monthly digest of the new devices, certificates and manufacturers added to EUDAMED — straight to your inbox.

By subscribing, you accept the General Personal Data Protection Policy.Check the consent box to subscribe.

Infographic — Is your software a Medical Device?

MD Atlas
Documents

Regulatory guidance

Infographic

Is your software a Medical Device?

Published Mar 1, 2021

EN

Reference

Infographic

Source

MDCG

Topic

New technologies

Published

Mar 1, 2021

Languages

EN

Official document

Open document (PDF)View on the official source

© European Union — European Commission, DG SANTE. Reuse under CC BY 4.0.

Related documents

MDCG 2025-9
Guidance on Breakthrough Devices (BtX) under Regulations 2017/745 & 2017/746Note: Pilot to roll-out the guidance is expected to be launched in Q2 2026
Published Dec 1, 2025
MDCG 2019-11
Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746
Published Jun 1, 2025
MDCG 2025-4
Guidance on the safe making available of medical device software (MDSW) apps on online platforms
Published Jun 1, 2025
MDCG 2025-6
FAQ on Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA)
Published Jun 1, 2025