Implantable Devices
Most implantables are Grade III or IV. Additional requirements include:
- Biocompatibility — ISO 10993 with focus on long-term implantation effects
- Sterilisation validation — all implantables supplied sterile
- Robust clinical data — mandatory (pivotal trial expected for Grade IV)
- Implant card — for certain high-risk implantables (cardiac, joint replacement)
- UDI-K at unit level — production identifier (PI) must be recorded in patient hospital record
Related pages
Implant card requirements High-risk implantables (cardiac pacemakers, artificial joints, vascular stents, spinal implants) must include an implant card for the patient containing: device name, model number, serial number, lot number, implantation date, and manufacturer contact information. The card facilitates future medical imaging, device identification in emergency situations, and post-market surveillance.
Clinical data requirements
Grade III implantables typically require clinical data from published literature or manufacturer-sponsored studies demonstrating safety and effectiveness. Grade IV implantables require a pivotal clinical trial with pre-approval MFDS involvement. The trial design must address the intended patient population, duration of follow-up appropriate to the implant's expected lifespan (short-term, medium-term, or long-term), and clinically meaningful endpoints. For novel implant designs without historical predicate data, MFDS may require a pre-submission meeting (Pre-IND equivalent) to align on trial protocols.