Device Classification

The sorting of medical devices into risk-based classes. The US has Classes I to III. The EU has classes I, IIa, IIb, and III. Each regime sets its own criteria.

Where it is written

21 CFR 860.3(c); Regulation (EU) 2017/745, Article 51(1)

Also called

medical device classification, risk class

Regimes

• Device Classification (US)The FDA's three classes for devices, set by whether general or special controls give reasonable assurance of safety and effectiveness. Class I needs general controls only. Class II needs special controls as well. Class III needs premarket approval.
• Device Classification (EU)The EU MDR divides devices into classes I, IIa, IIb, and III by intended purpose and inherent risk. The classes come from 22 rules in Annex VIII. The manufacturer states the class and the rules applied in the technical documentation.

Related terms