Active medical devices & energy-emitting devices
MDR Annex VIII, Rules 9–13 and Rule 22 govern active device classification. MDR Annex I, GSPR §14–16 and §19–22 cover design requirements for active and energy-emitting devices.
This site provides general information only and does not constitute legal or regulatory advice.
Definition of an active device
Under MDR Annex VIII, an active medical device is any device whose operation depends on a source of energy other than that generated by the human body or gravity, and which acts by converting that energy. Devices transmitting energy, substances, or other elements between an active device and the patient without significant change are not active devices.
Key examples:
- Powered surgical instruments (drills, saws)
- Infusion pumps
- Ventilators and anaesthetic machines
- Electrosurgical units
- Imaging equipment (X-ray, ultrasound, MRI)
- External defibrillators
- Implantable pacemakers and neurostimulators
- Therapeutic laser systems
- Radiation therapy equipment
Classification of active devices — Rules 9–13
| Rule | Default class | Elevated class trigger |
|---|---|---|
| Rule 9 | IIa (potentially dangerous energy delivery) | IIb if controlling Class IIb therapeutic devices |
| Rule 10 | IIa (active diagnostic, energy absorbed) | IIb for ionising radiation imaging |
| Rule 11 | Depends on software classification | See Software & SaMD classification |
| Rule 12 | I (administers substances in non-dangerous manner) | IIb if dangerous administration |
| Rule 13 | IIb | III if directly interacts with heart/CNS/central circulatory system |
Active implantable devices (pacemakers, cochlear implants, neurostimulators) are Class III under Rule 13.
Specific GSPR requirements for active devices
GSPR §14 — Energy source protection
Active devices connected to a power supply must:
- Continue to function safely during power fluctuation or interruption where a sudden stop would be dangerous
- Provide visual/audible alarm when power is insufficient
- Be protected against electromagnetic interference
GSPR §15–16 — Mechanical and energy risks
- Protection against moving parts, vibration, and unintended energy delivery
- Temperature limits for patient-contacting surfaces
- Safe default states on failure
GSPR §22 — Active implantable device requirements
- Battery life must be defined and communicated to the user
- In-situ function must be maintained within specification
- Device must remain stable in the implanted environment for its intended lifetime
Electromagnetic compatibility (EMC)
All electrically powered devices must comply with EN 60601-1-2 (EMC requirements for medical electrical equipment). This covers:
- Immunity to conducted and radiated electromagnetic disturbances
- Limits on emitted electromagnetic interference
- Testing in the intended use environment (e.g. hospital ward, ICU, home)
Software in active devices
Active devices that incorporate software (e.g. an infusion pump's dosing algorithm, an imaging system's AI analysis module) require the software component to be assessed under MDR Annex VIII Rule 11 as well as the hardware rules. The highest resulting class prevails.
Related pages
- Classification rules 1–22
- Software & SaMD classification
- Software as a Medical Device — special device types
- GSPR Chapter II — Design & construction
Official references
| Reference | Description |
|---|---|
| MDR Annex VIII Rules 9–13 | Active device classification |
| MDR Annex I §14–16, §19–22 | Active device GSPR |
| EN 60601-1:2006+A1:2013 | Medical electrical equipment safety |
| EN 60601-1-2:2015 | EMC for medical electrical equipment |