CA
A four-class cascade that asks recognisably similar questions to Annex VIII — and whose labels mean something different from the European ones that look identical.
Canada classifies under Schedule 1 of the Medical Devices Regulations, a rule cascade built on the same GHTF principles the European directives came from. So the questions feel familiar: invasiveness, duration, whether the device is active, contact with the central circulatory system. What differs is the shape of the answer. Canada uses four classes, I to IV, against the EU's four labels I, IIa, IIb and III — and the boundaries do not fall in the same places. The other structural difference is what the class buys you: a Class I device needs no device licence at all, only an establishment licence, while Classes II to IV each require a Medical Device Licence with escalating evidence.
Canadian Class III is not EU Class III. The Canadian scale runs to IV, so the top European tier maps somewhere between III and IV depending on the device, and the middle tiers do not align at all. Mapping by number is the specific mistake this market invites, because both systems use Roman numerals and one of them has an extra step.
NOTE —
| CLASS | RISK | INDEPENDENT REVIEW |
|---|---|---|
| I | Low | No licence required; establishment licence only |
| II | Low-moderate | Licence on manufacturer attestation |
| III | Moderate-high | Licence with detailed review |
| IV | High | Licence with fullest review |
Four: Class I to Class IV, assigned by the rules in Schedule 1 of the Medical Devices Regulations. Class I is the lowest risk and Class IV the highest.
No. The Canadian scale has four steps and the European scale has four labels arranged differently, so the numbers do not correspond. A device that is Class III in the EU may be Class III or Class IV in Canada depending on its characteristics.
A Class I device does not require a Medical Device Licence, but the company selling it generally requires an establishment licence. Classes II, III and IV each require a device licence, with the evidence required rising with the class.
The questionnaire classifies under the EU MDR and reports the Canada class alongside it, with the rules that produced each. Tick this market when you start.
