Implantable devices & implant card
MDR Art. 2(5) (definition); MDR Annex VIII Rule 8 (classification); MDR Art. 18 and Annex XV §2.12 (implant card); MDR Annex I §22–23 (GSPR for implantables). Active implantable devices are governed by the same regulation (AIMDs are now Class III under MDR).
This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.
Definition
An implantable device is any device, including those that are partially or wholly absorbed, that is intended to:
- Be totally introduced into the human body, or
- Replace an epithelial surface or the surface of the eye,
by clinical intervention, and is intended to remain in place after the procedure.
Devices that are partially implantable — introduced into the body through clinical intervention and remaining in place for at least 30 days — are also treated as implantable devices.
Classification of implantable devices
Most implantable devices are Class IIb or Class III under MDR Annex VIII Rule 8:
| Device type | Class |
|---|---|
| Long-term implantable — general | IIb |
| Implantable in teeth | III |
| Implantable in spine | III |
| Total joint replacements (hip, knee, shoulder) | III |
| Breast implants | III |
| Penile implants | III |
| Long-term implantable in contact with CNS | III |
| Long-term implantable in contact with central circulatory system | III |
| Long-term implantable in contact with heart | III |
| Active implantable devices (pacemakers, cochlear implants, neuro-stimulators) | III |
GSPR requirements specific to implantable devices
GSPR §22 — Active implantable devices
Active implantable devices must:
- Have defined battery life communicated clearly to users
- Maintain function within specification for the intended implant period
- Be stable and compatible with the surrounding biological environment throughout lifetime
GSPR §6 — Long-term biological safety
Implantable devices are subject to the most stringent biological evaluation requirements under EN ISO 10993-1, including:
- Chronic toxicity and genotoxicity testing
- Implantation testing (tissue reaction)
- Haemocompatibility (for blood-contacting implants)
- Carcinogenicity assessment for long-term implants
- Degradation testing where materials degrade in vivo
Fatigue and wear testing
Mechanical implants (orthopaedic, cardiovascular) require extensive preclinical testing:
- Fatigue testing to simulate years of cyclic loading
- Wear simulation (tribology)
- Corrosion resistance testing
- Dimensional and material verification
Clinical evidence requirements for implantables
Implantable devices, particularly Class III implantables, face the most demanding clinical evidence requirements:
- Clinical investigations are expected for novel Class III implantable devices
- Long-term follow-up is required — short-term safety data is not sufficient; 5+ year data is often expected for permanent implants
- Post-market clinical follow-up (PMCF) is particularly important for implantables: implant registers and long-term outcome studies are common PMCF methods
- The expert panel consultation (Art. 54) applies to new Class III implantable devices
The implant card — MDR Art. 18
For every implantable device (Class IIb and III, and Class IIa devices for surgically implanted devices), manufacturers must provide an implant card to accompany the device.
What the implant card must contain
Per MDR Art. 18 and Annex XV §2.12, the implant card must include:
| Element | Description |
|---|---|
| Device identification | Name, type, model, serial number |
| UDI-DI and UDI-PI | Enables tracing the specific unit |
| Manufacturer information | Name and address |
| Expiry date (if applicable) | For bioresorbable or time-limited implants |
| Warnings and precautions | MRI compatibility, electromagnetic interference, precautions for future procedures |
| Website / contact | Where further information can be found |
Who gives it to the patient?
The healthcare institution performing the implantation procedure must ensure the patient receives the implant card. The manufacturer provides the cards (or the means to generate them — e.g. a printed template); the hospital completes them and gives them to the patient.
Why it matters to the patient
The implant card enables:
- Future healthcare providers to identify the implanted device
- Patients to know if they have MRI restrictions
- Rapid device identification in a safety alert or recall
- Traceability in a multi-country context
EUDAMED and implantable device traceability
Implantable devices have heightened EUDAMED registration and UDI requirements:
- Serial numbers (unit-level UDI-PI) are required for individual implant traceability
- Healthcare institutions are required to store UDI data for implanted devices in their patient records
- National implant registries (where they exist) complement EUDAMED traceability
Specific implantable device categories
Total joint replacements
Among the highest-volume implantable device categories. Class III. Require:
- Long-term clinical evidence (typically 10-year data for primary joints)
- Tribological testing (wear)
- PMCF via national joint registries (NJR) in member states where they operate
Spinal implants
Class III. Require significant biomechanical testing and long-term clinical evidence. MRI compatibility assessment is critical.
Cardiovascular implants (stents, valves, occluders)
Class III. Require haemocompatibility, durability, and in many cases extensive clinical investigation data.
Cochlear implants and auditory implants
Class III active implantable devices. Battery life, hermetic sealing, and long-term biological compatibility are key.
Related pages
- Classification rules 1–22
- Active medical devices
- Devices incorporating a medicinal substance
- UDI labelling requirements
- PMCF plan and evaluation report
Official references
| Reference | Description |
|---|---|
| MDR Art. 2(5) | Implantable device definition |
| MDR Annex VIII Rule 8 | Classification rules for implantables |
| MDR Art. 18 | Implant card requirement |
| MDR Annex I §6, §22 | GSPR for implantable and active devices |
| EN ISO 10993-6 | Tests for local effects after implantation |
| EN ISO 14242 series | Wear testing for hip joint prostheses |
| MDCG 2021-6 | Clinical evidence for legacy implantable devices |