Implantable devices
Implantable devices are addressed throughout the UK MDR 2002 — in classification rules (Schedule 2, Rule 8), Essential Requirements (Schedule 1), and post-market obligations. The definition of an implantable device is in Regulation 2(1) of the UK MDR 2002.
Definition of an implantable device
An implantable device is defined as any device, including those that are partially absorbed, which is intended:
- To be totally introduced into the human body, or
- To replace an epithelial surface or the surface of the eye, by surgical intervention and which is intended to remain after the intervention
Devices intended to be partially introduced by surgical intervention and to remain for a long term are also considered implantable.
Classification of implantable devices
Implantable devices are generally classified at Class IIb or Class III under the classification rules in Schedule 2:
| Type of implant | Classification |
|---|---|
| Long-term implant (>30 days), not in critical location (e.g., peripheral soft tissue) | Class IIb |
| Long-term implant in heart, central circulatory system, or CNS | Class III |
| Implant incorporating a medicinal substance | Class III |
| Implant incorporating human/animal tissue | Class III |
| Dental implants and restorations | Class IIa (dental) |
| Active implantable devices (powered implants) | AIMD (Part II) |
Most implants of clinical significance are Class III or AIMD — the two highest-risk categories.
Additional Essential Requirements for implantable devices
Schedule 1 of UK MDR 2002 imposes additional requirements specific to implantable devices:
Biocompatibility and material requirements:
- All materials that will contact tissues, cells, or body fluids must be evaluated for biocompatibility (ISO 10993 series)
- Chemical leaching, corrosion, and wear particle generation must be assessed
- Long-term stability of materials in the biological environment
Mechanical requirements:
- Fatigue resistance under cyclic loading representative of expected in-vivo conditions
- Wear testing for articulating surfaces (orthopaedic implants)
- Corrosion testing for metallic implants in physiological environments
Explantability:
- Where the device is intended to be removable, it must be designed to enable safe removal
- Instructions for removal must be provided
Patient information:
- Implantable devices require an implant card — a card provided to the patient at implantation containing device identification information, manufacturer details, and relevant warnings or MRI conditions
Implant cards
Manufacturers of implantable devices must ensure that a patient implant card is provided with each device. The implant card must contain:
- Device name, model, and serial/lot number
- Manufacturer name and contact details
- UKRP details (for non-UK manufacturers)
- Any relevant warnings or precautions (e.g., MRI conditions, airport security)
- UDI (as UDI implementation progresses in the UK)
The card is given to the patient at the time of implantation and should be carried by them. This is particularly important for:
- MRI compatibility information (pacemakers, neurostimulators)
- Airport/security scanner information
- Emergency medical identification
Long-duration traceability records
For implantable devices, distribution and implantation records must be retained for a minimum of 15 years (or the expected lifetime of the device if longer):
- Device batch/lot number and serial number (for individually serialised devices)
- Implanting healthcare facility
- Date of implantation
- Patient identifier (held by the facility, not necessarily by the manufacturer)
This traceability enables rapid notification of patients if a safety recall or field safety corrective action is required.
Post-market obligations for implantable devices
Implantable devices carry the most stringent post-market obligations:
- Annual PSURs (for Class IIb and Class III implants)
- Active PMS programme — structured collection of clinical follow-up data
- Registry participation — MHRA encourages participation in national implant registries (e.g., National Joint Registry, UK Cardiac Device Registry)
- Vigilance — all suspected device-related serious incidents must be reported promptly to MHRA
Related pages
- Active implantable devices (AIMD)
- Classification rules — Rule 8
- Devices incorporating a medicinal substance
- Post-market surveillance
- Vigilance reporting
Official references
| Reference | Description |
|---|---|
| UK MDR 2002, Regulation 2(1) | Implantable device definition |
| UK MDR 2002, Schedule 2, Rule 8 | Classification of implantable devices |
| UK MDR 2002, Schedule 1 | Essential Requirements including implant-specific requirements |
| ISO 10993 series | Biological evaluation of medical devices |
| ISO 5832 series | Metallic materials for surgical implants |
| ISO 14708 series | Implants for surgery — active implantable devices |