Guidance on Implant Card – Device types

MDCG 2021-11

Guidance on Implant Card –

‘Device types’

May 2021

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 a representative of the

European Commission chairs it.

The document is not a European Commission document and it cannot be regarded

as reflecting the official position of the European Commission. Any views expressed

in this document are not legally binding and only the Court of Justice of the European Union can give binding interpretations of Union law.

Implant Card – ‘Device types’ 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 Craniofacial 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 coil Version 1.1

81. Embolic beads Embolic bead 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