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MDCG 2021-11

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.

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 DeviceImplantable Medical ‘Device type’Publication
1.Implantable cardiac pacemakerPacemakerVersion 1.1
2.Implantable cardiac leadless pacemakerLeadless pacemakerVersion 1.1
3.Implantable cardiac monitorCardiac monitorVersion 1.1
4.Implantable cardiac defibrillatorDefibrillatorVersion 1.1
5.Cardiac leadCardiac leadVersion 1.1
6.Pacemaker ICD LeadPacemaker ICD leadVersion 1.1
7.Neural leadNeural leadVersion 1.1
8.Spinal Neural stimulatorSpinal stimulatorVersion 1.1
9.Brain Neural stimulatorBrain stimulatorVersion 1.1
10.Implantable pumpMedicinal pumpVersion 1.1
11.Cranial shuntBrain shuntVersion 1.1
12.CSF shuntCSF shuntVersion 1.1
13.Lumbar shuntLumbar shuntVersion 1.1
14.Hydrocephalus valve implantBrain valveVersion 1.1
15.CSF ValveCSF ValveVersion 1.1
16.Lumbar valveLumbar valveVersion 1.1
17.Cranio-facial reconstruction ImplantCraniofacial implantVersion 1.1
18.Dura patchDura patchVersion 1.1
19.Intraocular lensIntraocular lensVersion 1.1
20.Ophthalmic filtration drainGlaucoma drainVersion 1.1
21.Ophthalmic liquidOphthalmic liquidVersion 1.1
22.Mechanical aortic valveMech. Aortic ValveVersion 1.1
23.Mechanical mitral valveMech. Mitral ValveVersion 1.1
20.Ophthalmic filtration drainGlaucoma drainVersion 1.1
21.Ophthalmic liquidOphthalmic liquidVersion 1.1
22.Mechanical aortic valveMech. Aortic ValveVersion 1.1
23.Mechanical mitral valveMech. Mitral ValveVersion 1.1
24.Mitral valve bio prosthesisBio. Mitral valveVersion 1.1
25.Pulmonary valve bio prosthesisBio. Pulmonary valveVersion 1.1
26.Valved graftValved graftVersion 1.1
27.Left atrial appendage closureAtrial closureVersion 1.1
28.Neurovascular coilNeurovascular coilVersion 1.1
29.Neurovascular stentNeurovascular stentVersion 1.1
30.Neurovascular flow diverterNeurovascular stentVersion 1.1
31.Mitral annuloplasty ringMitral ringVersion 1.1
32.Annuloplasty bandAnnuloplasty bandVersion 1.1
33.Vascular patchVascular patchVersion 1.1
34.Vascular plugVascular plugVersion 1.1
35.Aortic valve bio prosthesisBio. Aortic valveVersion 1.1
36.PFO-OccluderPFO OccluderVersion 1.1
37.Aortic stent graftAortic stent graftVersion 1.1
38.Aortic anchorAortic anchorVersion 1.1
39.Oesophageal stentOesophageal stentVersion 1.1
40.Enteral stentEnteral stentVersion 1.1
41.Biliary stentBiliary stentVersion 1.1
42.Tracheobronchial stentTracheobronchial stentVersion 1.1
43.Pancreatic stentPancreatic stentVersion 1.1
44.Renal stentRenal stentVersion 1.1
45.Endoscopic drainage stentDrainage stentVersion 1.1
46.Coronary stentCoronary stentVersion 1.1
47.Self-expanding peripheral stentPeripheral stentVersion 1.1
48.Balloon expandable peripheral stentPeripheral stentVersion 1.1
49.Venous stentVenous stentVersion 1.1
50.Hip joint replacementHip implantVersion 1.1
51.Knee joint replacementKnee implantVersion 1.1
52.Shoulder joint replacementShoulder implantVersion 1.1
53.Elbow replacement systemElbow implantVersion 1.1
54.Hand joint replacementHand implantVersion 1.1
55.Wrist implantWrist implantVersion 1.1
56.Extremity replacement componentAnkle implantVersion 1.1
57.Extremity replacement componentFoot implantVersion 1.1
58.Spinal stentSpinal stentVersion 1.1
59.Spinal fusion deviceSpinal fusionVersion 1.1
60.Spinal fixation systemSpinal fixationVersion 1.1
61.Spinal stabilisation systemSpinal stabiliserVersion 1.1
62.AnchorBone anchorVersion 1.1
63.Bone nailing implantBone nailVersion 1.1
64.Bone distraction deviceBone distractionVersion 1.1
65.Cranial clampCranial clampVersion 1.1
66.Bone cementBone cementVersion 1.1
67.Bone waxBone waxVersion 1.1
68.Bone plugBone plugVersion 1.1
69.Hernia meshHernia meshVersion 1.1
70.Flexible plateTissue plateVersion 1.1
71.Breast implantBreast implantVersion 1.1
72.Intraperitoneal portIntraperitoneal portVersion 1.1
73.Vein adhesiveVein adhesiveVersion 1.1
74.Absorbable haemostatsAbsorbable haemostatsVersion 1.1
75.Ureteral bypassUreteral bypassVersion 1.1
76.Urinary incontinence – injectable bulking agentBladder implantVersion 1.1
77.Ureteral stentUreteral stentVersion 1.1
78.Enteral feeding devicesEnteral feedingVersion 1.1
79.Fiducial markerFiducial markerVersion 1.1
80.Embolic coilsEmbolic coilVersion 1.1
81.Embolic beadsEmbolic beadVersion 1.1
82.Embolic particlesEmbolic particlesVersion 1.1
83.Prostatic implantProstatic implantVersion 1.1
84.Urinary incontinence slingIncontinence slingVersion 1.1
85.Pelvic organ prolapse meshPelvic meshVersion 1.1
86.Testicular prosthesis – saline-filledTesticular prosthesisVersion 1.1
87.Septal PatchHeart patchVersion 1.1
88.Gastric BandGastric bandVersion 1.1

Revision History

May 2021 | Rev. 1.1

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