Medical device class III
Class III is the highest risk class in the MDR's four-level classification system. Class III products are in direct contact with the cardiac muscle, cardiovascular system, or central nervous system; are resorbable; or contain substances that are systemically absorbed.
Typical Class III products:
- Coronary stents and vascular implants
- Heart valves
- Pacemakers
- Bone substitutes and resorbable implants
- Breast implants
- Neurostimulators
Conformity assessment (strictest requirements):
- Notified Body mandatory
- EU type-examination or full QMS assessment
- Clinical investigations generally required
- PMCF (Post-Market Clinical Follow-up) mandatory
- UDI mandatory since May 2021
Special feature: for certain Class III implants, the Notified Body must consult an EU Commission expert panel (EURA) before issuing a certificate.
Gloves are not Class III. Class III relates exclusively to products with very high patient risk within the body.
Frequently asked questions
What are typical Class III medical devices?
Coronary stents, heart valves, pacemakers, resorbable bone implants, breast implants, and neurostimulators. Common feature: direct contact with vital body tissue or critical systems and/or resorption in the body.
Why are the strictest requirements applied to Class III?
Class III products rarely fail without serious consequences - pacemaker failure can be life-threatening. The risk potential justifies maximum regulatory control: clinical studies, expert panels, ongoing follow-up.