Medical device class II b
Class IIb medical devices form the third tier in the MDR's four-level classification system and cover products with higher risk potential that do not fall into the highest Class III.
Typical Class IIb products:
- Ventilators and respiratory devices
- Defibrillators
- Surgical lighting systems
- Surgical laser devices
- Haemodialysis filters
- Infusion pumps (depending on intended use)
- Notified Body mandatory
- Stricter requirements than Class IIa: Annex IX requires the Notified Body to specifically assess technical documentation for Class IIb
- Annex X (EU type-examination) also available
Distinction from Class IIa: Class IIb covers products with potentially more severe consequences in case of failure. The classification rules in MDR Annex VIII determine whether a product is IIa or IIb.
Distinction from Class III: Class III covers the highest-risk products (implants, products in direct cardiac contact, resorbable products).
Frequently asked questions
What is the difference between Class IIa and Class IIb?
Both require a Notified Body. Class IIb has a higher risk potential: under Annex IX, the Notified Body must explicitly assess the technical documentation for Class IIb - which is not prescribed to the same extent for IIa.
Which products typically fall into Class IIb?
Ventilators, defibrillators, surgical lasers, haemodialysis filters, infusion pumps and similar products with elevated failure risk. The distinction from IIa and III follows the classification rules in MDR Annex VIII.