UK
Great Britain never adopted the MDR. Classification still runs on the 18 rules the MDD used, which means several devices that were up-classified in the EU in 2021 were not up-classified here.
The divergence is not a matter of interpretation — it is a different rule set. Great Britain applies the classification rules of the UK Medical Devices Regulations 2002, which derive from Directive 93/42/EEC: 18 rules rather than 22. The practical effect is concentrated in the places where the MDR deliberately raised the bar. Software has no equivalent of MDR Rule 11 and usually remains Class I. Surgical mesh and total joint replacements, named as Class III in MDR Rule 8, are not named in the directive and sit lower. A manufacturer holding a UK class from a British assessment and assuming it carries into the EU is holding a number that was calculated under a superseded framework.
The labels are identical — I, IIa, IIb, III — which makes this the most deceptive comparison on the site. Same letters, different rules, and in a meaningful minority of cases a different answer. Northern Ireland is a separate matter again: under the Windsor Framework it follows the EU MDR, so a device can carry one class in Great Britain and another a few miles away.
NOTE —
| CLASS | RISK | INDEPENDENT REVIEW |
|---|---|---|
| I | Low | Self-declaration, with exceptions |
| IIa | Medium | Approved Body required |
| IIb | Medium-high | Approved Body required |
| III | High | Approved Body required |
No. Great Britain applies the UK Medical Devices Regulations 2002, whose classification rules derive from Directive 93/42/EEC — 18 rules rather than the MDR's 22. The class labels are the same, so the difference is easy to miss.
Because MDR Rule 11 has no counterpart in the directive. Rule 11 moved most medical device software from Class I to at least Class IIa in the EU; Great Britain never adopted it, so software is classified under the older rules and frequently remains Class I.
No. Under the Windsor Framework, Northern Ireland follows the EU MDR. The classification described here applies to Great Britain — England, Scotland and Wales.
No. They are separate market access marks resting on separate frameworks, assessed by Approved Bodies in Great Britain and Notified Bodies in the EU. Holding one does not confer the other.
The questionnaire classifies under the EU MDR and reports the United Kingdom (Great Britain) class alongside it, with the rules that produced each. Tick this market when you start.
