The European Commission has expanded the list of implantable and Class III devices that may be exempt from clinical investigations when based on well-established technologies.
Key takeaways :
- Extension of the list of well-established technologies.
- A broad range of devices are affected, particularly in the dental, orthopedic, cardiovascular and surgical fields.
- Exemption from clinical investigations does not remove the requirement to demonstrate safety and performance through an MDR-compliant clinical evaluation.
Key message : this regulation could simplify clinical strategies for certain manufacturers while maintaining clinical evidence requirements.
Published on 29 June 2026, with entry into force 20 days later.
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