Guide
Medical device classification: FDA and EU MDR explained
Classification sorts devices by risk, and it decides almost everything that follows: the route to market, the evidence you need and who reviews it. The US and the EU use different systems, so a device can sit in different classes in each market.
The systems
How each market classifies devices
FDA: Class I, II and III
Classes rise with risk. Many Class I devices are exempt from premarket review, most Class II devices need a 510(k), and Class III devices usually need a PMA.
FDA: finding your class
Search the FDA product classification database for a matching device type; it gives the regulation number, product code and class. New low-to-moderate risk devices without a predicate can use De Novo.
EU MDR: Class I, IIa, IIb and III
Classes are assigned by applying the 22 rules in Annex VIII, based on factors such as invasiveness, duration of use and whether the device is active.
EU MDR: who reviews it
Most Class I devices are self-declared. Class Is, Im, Ir and all higher classes need a notified body to assess conformity.
Getting it right
How to classify a device
- 1Write a precise intended purpose — classification follows from it.
- 2For the US, find the matching classification regulation and product code.
- 3For the EU, work through the Annex VIII rules and record why each applies or not.
- 4Document the rationale and keep it under change control, since design changes can change the class.
- 5When unsure, use an FDA 513(g) request or ask your notified body before building the evidence plan.
Where Qevatrix fits
Classification per product, per market
RegulatoryOS records each product's classification, product code and pathway in every market you sell in, alongside its clearances and registrations.
More guides
See all guidesRegulatoryOS
510(k) submission guide
How premarket notification works: predicates, substantial equivalence, and what a submission has to contain.
QualityOS
FDA QMSR transition guide
What changes as 21 CFR Part 820 aligns with ISO 13485:2016, and how to prepare your quality system.
QualityOS
ISO 13485 in 2026
What is being worked on in the standard, what stays the same, and what to plan for.
This guide is an orientation, not regulatory advice. Confirm classification against the FDA classification database, EU MDR Annex VIII and MDCG 2021-24.