MDR · UKCA · FDA · AI Act
Resources.
Guides and reference material on EU MDR, UKCA, FDA, the EU AI Act and EUDAMED, for medical device manufacturers and regulatory teams.
Index
18 articles
01POLICY
DCB0129 and DCB0160 under review: what manufacturers should know
What NHS England's review of its clinical safety standards found, why the current versions still carry only a duty to have regard, and what a revision could change.
6 min read
02UKCA
UKCA marking for software medical devices in Great Britain
Why software can take a lower class in Great Britain than under EU MDR, how long a CE mark still works, and the GB obligations that apply whichever route you take.
11 min read
03FDA
FDA 510(k) for software as a medical device: the US routes
510(k), De Novo or PMA, how predicates really work for software, what a PCCP lets you change, and what your ISO 13485 system does not carry across.
9 min read
04SaMD
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
05SaMD
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
06AI
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
07SaMD
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
08MDR
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
09MDR
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
10MDR
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
11EUDAMED
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
12POLICY
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
13MDR
What is EU MDR?
A plain-language overview of the regulation, who it applies to, and what it means in practice.
8 min read
14MDR
Clinical Evaluation Report
A practical explainer on CER requirements, methodology, and why preparation is so resource-intensive.
7 min read
15MDR
PMS, PSUR, and PMCF
Understand the post-market surveillance framework and how it connects back into your device file.
9 min read
16AI
AI Act × MDR Overlap
Why AI-enabled medical devices face a dual-compliance challenge, and why documentation models must evolve.
10 min read
17MDR
Technical Documentation
See how Annex II and Annex III fit together and why internal consistency matters so much.
7 min read
18SME
EU MDR for SMEs
A focused look at the burden on smaller manufacturers and the practical steps they should take.
6 min read
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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