MDCG 2021-11 Rev.0
Guidance on Implant Card – ‘Device types’
Disclaimer: This document is an interactive version of the original MDCG document. We will keep it up-to-date.
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.
Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (MDR)
Version 1.1
According to Article 18 (a) of the MDR, the manufacturer of an implantable medical device shall provide together with the device, information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer.
In accordance with the instructions laid out in MDCG 2019-8, the implant card should also indicate a ‘device type’ for the implantable medical device in question (see in red below).
As such, this document provides a non-exhaustive list of implantable medical ‘device types’ in order to aid manufacturers in allocating an appropriate term for this requested information.
A balance between the information a patient and a healthcare professional require was a main driver behind the suggested ‘device types’.
This document will be updated, as appropriate, and following the agreement of the MDCG.
| # | Implantable Medical Device | Implantable Medical ‘Device type’ | Publication |
|---|---|---|---|
| 1. | Implantable cardiac pacemaker | Pacemaker | Version 1.1 |
| 2. | Implantable cardiac leadless pacemaker | Leadless pacemaker | Version 1.1 |
| 3. | Implantable cardiac monitor | Cardiac monitor | Version 1.1 |
| 4. | Implantable cardiac defibrillator | Defibrillator | Version 1.1 |
| 5. | Cardiac lead | Cardiac lead | Version 1.1 |
| 6. | Pacemaker ICD Lead | Pacemaker ICD Lead | Version 1.1 |
| 7. | Neural lead | Neural lead | Version 1.1 |
| 8. | Spinal Neural stimulator | Spinal stimulator | Version 1.1 |
| 9. | Brain Neural stimulator | Brain stimulator | Version 1.1 |
| 10. | Implantable pump | Medicinal pump | Version 1.1 |
| 11. | Cranial shunt | Brain shunt | Version 1.1 |
| 12. | CSF shunt | CSF shunt | Version 1.1 |
| 13. | Lumbar shunt | Lumbar shunt | Version 1.1 |
| 14. | Hydrocephalus valve implant | Brain valve | Version 1.1 |
| 15. | CSF Valve | CSF Valve | Version 1.1 |
| 16. | Lumbar valve | Lumbar valve | Version 1.1 |
| 17. | Cranio-facial reconstruction Implant | Cranio-facial reconstruction Implant | Version 1.1 |
| 18. | Dura patch | Dura patch | Version 1.1 |
| 19. | Intraocular lens | Intraocular lens | Version 1.1 |
| 20. | Ophthalmic filtration drain | Glaucoma drain | Version 1.1 |
| 21. | Ophthalmic liquid | Ophthalmic liquid | Version 1.1 |
| 22. | Mechanical aortic valve | Mech. Aortic Valve | Version 1.1 |
| 23. | Mechanical mitral valve | Mech. Mitral Valve | Version 1.1 |
| 24. | Mitral valve bio prosthesis | Bio. Mitral valve | Version 1.1 |
| 25. | Pulmonary valve bio prosthesis | Bio. Pulmonary valve | Version 1.1 |
| 26. | Valved graft | Valved graft | Version 1.1 |
| 27. | Left atrial appendage closure | Atrial closure | Version 1.1 |
| 28. | Neurovascular coil | Neurovascular coil | Version 1.1 |
| 29. | Neurovascular stent | Neurovascular stent | Version 1.1 |
| 30. | Neurovascular flow diverter | Neurovascular stent | Version 1.1 |
| 31. | Mitral annuloplasty ring | Mitral ring | Version 1.1 |
| 32. | Annuloplasty band | Annuloplasty band | Version 1.1 |
| 33. | Vascular patch | Vascular patch | Version 1.1 |
| 34. | Vascular plug | Vascular plug | Version 1.1 |
| 35. | Aortic valve bio prosthesis | Bio. Aortic valve | Version 1.1 |
| 36. | PFO-Occluder | PFO-Occluder | Version 1.1 |
| 37. | Aortic stent graft | Aortic stent graft | Version 1.1 |
| 38. | Aortic anchor | Aortic anchor | Version 1.1 |
| 39. | Oesophageal stent | Oesophageal stent | Version 1.1 |
| 40. | Enteral stent | Enteral stent | Version 1.1 |
| 41. | Biliary stent | Biliary stent | Version 1.1 |
| 42. | Tracheobronchial stent | Tracheobronchial stent | Version 1.1 |
| 43. | Pancreatic stent | Pancreatic stent | Version 1.1 |
| 44. | Renal stent | Renal stent | Version 1.1 |
| 45. | Endoscopic drainage stent | Drainage stent | Version 1.1 |
| 46. | Coronary stent | Coronary stent | Version 1.1 |
| 47. | Self-expanding peripheral stent | Peripheral stent | Version 1.1 |
| 48. | Balloon expandable peripheral stent | Peripheral stent | Version 1.1 |
| 49. | Venous stent | Venous stent | Version 1.1 |
| 50. | Hip joint replacement | Hip implant | Version 1.1 |
| 51. | Knee joint replacement | Knee implant | Version 1.1 |
| 52. | Shoulder joint replacement | Shoulder implant | Version 1.1 |
| 53. | Elbow replacement system | Elbow implant | Version 1.1 |
| 54. | Hand joint replacement | Hand implant | Version 1.1 |
| 55. | Wrist implant | Wrist implant | Version 1.1 |
| 56. | Extremity replacement component | Ankle implant | Version 1.1 |
| 57. | Extremity replacement component | Foot implant | Version 1.1 |
| 58. | Spinal stent | Spinal stent | Version 1.1 |
| 59. | Spinal fusion device | Spinal fusion | Version 1.1 |
| 60. | Spinal fixation system | Spinal fixation | Version 1.1 |
| 61. | Spinal stabilisation system | Spinal stabiliser | Version 1.1 |
| 62. | Anchor | Bone anchor | Version 1.1 |
| 63. | Bone nailing implant | Bone nail | Version 1.1 |
| 64. | Bone distraction device | Bone distraction | Version 1.1 |
| 65. | Cranial clamp | Cranial clamp | Version 1.1 |
| 66. | Bone cement | Bone cement | Version 1.1 |
| 67. | Bone wax | Bone wax | Version 1.1 |
| 68. | Bone plug | Bone plug | Version 1.1 |
| 69. | Hernia mesh | Hernia mesh | Version 1.1 |
| 70. | Flexible plate | Tissue plate | Version 1.1 |
| 71. | Breast implant | Breast implant | Version 1.1 |
| 72. | Intraperitoneal port | Intraperitoneal port | Version 1.1 |
| 73. | Vein adhesive | Vein adhesive | Version 1.1 |
| 74. | Absorbable haemostats | Absorbable haemostats | Version 1.1 |
| 75. | Ureteral bypass | Ureteral bypass | Version 1.1 |
| 76. | Urinary incontinence – injectable bulking agent | Bladder implant | Version 1.1 |
| 77. | Ureteral stent | Ureteral stent | Version 1.1 |
| 78. | Enteral feeding devices | Enteral feeding | Version 1.1 |
| 79. | Fiducial marker | Fiducial marker | Version 1.1 |
| 80. | Embolic coils | Embolic coils | Version 1.1 |
| 81. | Embolic beads | Embolic beads | Version 1.1 |
| 82. | Embolic particles | Embolic particles | Version 1.1 |
| 83. | Prostatic implant | Prostatic implant | Version 1.1 |
| 84. | Urinary incontinence sling | Incontinence sling | Version 1.1 |
| 85. | Pelvic organ prolapse mesh | Pelvic mesh | Version 1.1 |
| 86. | Testicular prosthesis – saline-filled | Testicular prosthesis | Version 1.1 |
| 87. | Septal Patch | Heart patch | Version 1.1 |
| 88. | Gastric Band | Gastric band | Version 1.1 |