MDR · IVDR · EUDAMED

Resources.

Guides and reference material on EU MDR, IVDR, and EUDAMED - for medical device manufacturers and regulatory teams.

Index

15 ARTICLES

Is your software a medical device? MDR Rule 11 explained

Qualification before classification, Rule 11 broken into sub-rules 11a to 11c, four worked examples, and what the December 2025 reform proposal would change.

11 min read

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SaMD

SaMD vs SiMD: what actually changes under EU MDR

Neither term appears in the MDR. What the regulation asks is whether software goes to market in its own right or as an integral part of a device, and that changes who certifies it.

10 min read

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AI model updates: change control under MDR and the AI Act

Two regimes, two triggers. MDR Annex IX 4.10, AI Act substantial modification, the Article 43(4) pre-determined change route, and the deadline that just moved to 2028.

12 min read

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SaMD

IEC 62304 explained: software safety classes A, B and C

Why your software safety class is not your MDR device class, how external risk controls lower it, what SOUP obliges you to track, and where Edition 2 really stands.

11 min read

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MDR

Legal manufacturer under EU MDR: definition and obligations

The MDR does not define the phrase. It defines the manufacturer, and the test turns on whose name the device is marketed under, not who built it.

9 min read

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MDR

How to classify a medical device under Annex VIII

The classification rules behind every MDR route to market: how the rules are structured, how the implementing rules resolve conflicts, and where devices get up-classified.

7 min read

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MDR

Class I Technical Documentation Under MDR: Why “Low Risk” No Longer Means Simple

Class I devices are still low risk clinically, but the documentation burden has grown sharply - especially for Class Is, Im and Ir manufacturers.

10 min read

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EUDAMED

The day after May 28: what EUDAMED actually changes

Everyone is preparing for a deadline. The harder problem is May 29 - the day EUDAMED stops being a filing and starts being a permanent discipline.

12 min read

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POLICY

The Class I Squeeze: why the lowest-risk devices face the highest cliff

Under MDR, many former Class I devices have been quietly up-classified into territory that requires a Notified Body - and the December 2028 wall is closer than it looks.

6 min read

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MDR

What is EU MDR?

A plain-language overview of the regulation, who it applies to, and what it means in practice.

8 min read

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MDR

Clinical Evaluation Report

A practical explainer on CER requirements, methodology, and why preparation is so resource-intensive.

7 min read

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MDR

PMS, PSUR, and PMCF

Understand the post-market surveillance framework and how it connects back into your device file.

9 min read

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AI Act × MDR Overlap

Why AI-enabled medical devices face a dual-compliance challenge - and why documentation models must evolve.

10 min read

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MDR

Technical Documentation

See how Annex II and Annex III fit together and why internal consistency matters so much.

7 min read

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SME

EU MDR for SMEs

A focused look at the burden on smaller manufacturers and the practical steps they should take.

6 min read

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Cadence

Written when there is something worth saying.

Field notes are written by the team building Artifakt - operators from medtech and engineering working with manufacturers preparing for EU MDR. No publishing schedule, no SEO filler. Each piece exists because the underlying problem keeps coming up in the work.

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We work hands-on with a small number of medical device manufacturers on EU MDR and the EU AI Act.

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