Which topics does the Medical Device Regulation cover?
A topic model sorted 1,428 paragraphs of the MDR into fifteen themes. Manufacturer obligations and conformity take 23.9 percent of the text. Notified body assessment takes 12.5 percent, certifications a further 5.8 percent. Vigilance and field safety take 6.8 percent.
Notably, the regulation seems to devote six times more text to establishing conformity before market entry than to monitoring performance after devices are placed on the market.
The fifteen topics, placed by similarity (axes have no units)
How is MDR wired?
In this project, a provision is the smallest unit of the MDR, such as an article paragraph or annex section. The analysis identified 2,124 with 1,492 internal cross-references. 198 provisions point to other documents. This suggests that most provisions stand on their own.
Annex I, the general safety and performance requirements, is referenced 67 times, more than any other provision, and references 16 in turn.
Article 52, conformity assessment, references 62 provisions and is referenced by 24. It ranks first on betweenness, so most paths through the regulation pass through it.
Similar to the previous analysis, the reference network also organizes around conformity assessment procedures, again suggesting that the MDR concentrates on approval and market entry.
Which terms are co-referenced?
Article 2 defines 71 terms. Across the regulation, in 93 instances, these terms are co-referenced. Interestingly, twelve terms are never co-referenced.
A longer loop of co-referenced terms runs through ten terms, reflecting a typical device lifecycle, from putting into service to clinical evaluation and post-market surveillance and back.
Not every definition is self-contained. Some are written using other defined terms. For example, "field safety notice" is defined through "field safety corrective action", which is defined through "serious incident", which is defined through "incident".
Who does MDR hold accountable?
In EU law, "shall" creates a binding duty. The analysis identified 1,645 binding duties. Just 600 name the actor that has to comply. The rest leave it open. 441 provisions are written in the passive voice with no actor at all, e.g., "serious incidents shall be reported". Another 604 attach the requirement to an object rather than a person; for instance, what a device must include, or what a document must state.
Among the duties that do name an actor, notified bodies hold 188 duties against, while manufacturers hold 124. The MDR seems to assign more explicit duties to notified bodies than to manufacturers. However, that gap likely reflects the nature of the text. For instance, Annex I states manufacturer requirements as properties of the device.
Data Source: Regulation (EU) 2017/745. Status: 1 January 2026.
Reference network of the largest component
Full reference network