The European Commission has expanded the list of class IIb implantable devices exempt from systematic technical documentation assessment by notified bodies.
Key takeaways :
- New categories of well-established technologies added to the exemption list.
- Includes devices such as catheters, bone substitutes, dental implants and spinal fixation devices.
- Objective: streamline conformity assessment for mature technologies with a proven safety and performance record.
Key message : manufacturers of eligible class IIb implantable devices may benefit from a lighter conformity assessment pathway under the MDR.
Published on 29 June 2026, with entry into force 20 days later.
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