Technical explanation
What it means
For medical devices, CE marking is a regulatory conformity concept and should not be confused with calibration, preventive maintenance or hospital acceptance testing.
Why it matters
- Provides European market conformity context.
- May appear on imported medical devices and accessories.
- Supports procurement and manufacturer-document review.
- Does not replace equipment calibration, electrical safety testing or service records.
How hospitals and biomedical teams use it
- Record CE-related documents in procurement or device master files where required.
- Follow manufacturer instructions for use, maintenance and calibration.
- Maintain hospital calibration and PM records separately.
- Check accessories, applied parts and service history during biomedical review.
Related services
ISO/IEC 17025 Calibration Services
NABL Accredited Calibration Laboratory
Electrical Safety Testing
IEC 60601 Testing
NABH Compliance Services
Equipment Validation
Helpful downloads
Frequently asked questions
Does CE marking mean the device does not need calibration?
No. CE marking and calibration status are different matters.
Should CE documents be kept with calibration certificates?
They can be kept in device master or procurement files, while calibration certificates should remain in biomedical service records.