Medical Device       
Medical Device Coordination Group Document                                               MDCG 2019-8 v2    
 
 
 
       
   MDCG 2019-8 v2  
Guidance document 
Implant Card relating to the application  
       of Article 18 Regulation (EU) 2017/745  
       of the European Pa rliament and of the Council  
       of 5 April 2017 on medical devices           
 
             March 2020 
 
 
  
 
This document has been endorsed b y the Medical Device Coordinat ion Group (MDCG) established by 
Article 103 of Regulation (EU) 2017/745. The MDCG is composed o f representatives of all Member 
States and it is chaired by a representative of the European Co mmission. 
The document is not a European Commission document and it canno t be regarded as reflecting the 
official position of the European Commission. Any views express ed in this document are not legally 
binding and only the Court of Justice of the European Union can  give binding interpretations of Union 
law. 
 
 
  Medical Devices: Guidance document 
Implant Card relating to the app lication of Article 18 Regulati on (EU) 2017/745 of the 
European Parliament and of the Council of 5 April 2017 on medic al devices 
 
  List of Content 
 
1. Scope ............................................................................................................... 4  
2. Purposes of the Implant Card ..................................................................... 4  
3. Legal consideration on Implant Card design ........................................... 4  
4. Information to be provided by the manufacturer on the Implant Card 
and information to be added by the health institution ........................... 5  
5. Use of symbols .............................................................................................. 6  
6. Language requirements on specific fields ................................................ 7  
7. Benefits of an informativ e instruction leaflet ........................................... 7  
8. Implant Card for implantable systems ...................................................... 7  
Annex I examples of principle designs of Implant Cards and leaflets ....... 8  
 
  1. Scope 
This document provides guidance for Memb er States, concerned industry and other 
stakeholders on a blueprint of an implant card (IC) required by the MDR (Regulation (EU) 
2017/745). It describes the intended use, cont ent and information to be provided by the 
manufacturer together on the IC and a definition of fields to be completed by the implanting 
healthcare institutions or healthcare provider s according to national law in Member States. 
Whereas the intended purpose and most of the da ta elements of the IC are already defined in 
Article 18 of the MDR, this document contains the description of other data elements which must be completed by the healthcare institution or healthcare provider and which must be considered by the individual Member State wh en implementing Article 18 MDR as required
1. 
2. Purposes of the Implant Card 
The aim of introducing an IC has been to achieve three main objectives: 
1. Enable the patient to identify the impl anted devices and to get access to other 
information related to the implanted device (e.g. via EUDAMED, and other websites). 
2. Enable patients to identify themselves as persons requiring special care in relevant 
situations e.g. security checks. 
3. Enabling e.g. emergency clinical staff or fi rst responder to be informed about special 
care/needs for relevant patients in case of emergency situations. 
3. Legal consideration on Implant Card design 
Article 18 MDR describes the requirements rega rding the IC which shall be provided by the 
manufacturer together with the device. Wherea s Article 18 para 1a) describes the information 
which shall be provided by the manufacturer on the IC, Article 18 pa r a  2  l a y s  d o w n  t h e  
obligation of Member States to require health in stitutions to provide the IC to the concerned 
patient. In accordance with Article 18, 1a) the manufact urer should provide th e following information 
on the IC (preferably on the card itself or, alternatively, as stickers to be placed by the clinician): 
 Device name; 
 Serial number, lot number; 
 Unique device identification (UDI); 
 Name, address and the website of manufacturer; 
 Device type.
2  
Article 18, 2 lays down that Member States shall require health institutions (or healthcare 
providers) inter alia to make available the IC to the relevant patient. The IC should bear their 
                                                      
1 This guidance doesn’t include the patient information described in Ar ticle 18 para 1 (b-d) which might 
be provided by the manufacturer by any means that allow rapid access to that information and that 
shall be stated in the language(s) determined by the concerned Member State.  
2 In Article 18 1a) of the MDR, the term “device model”  is used. However, this term which is not defined 
in the MDR, is part of the UDI-DI related info r m a t i o n  t o  b e  p r o v i d e d  t o  E U D A M E D .  T o  a v o i d  
duplication and in the context of the intended purpos e of the IC (to be used in situations requiring 
special care or in emergency situations), it is cons idered that reference to device model in the MDR for 
the purpose of the IC shall be read as reference to device type, like “pacemaker”, “hip implant”, etc. 
When the European Medical device nomenclature is made available, a “standardised” set of terms of 
this nomenclature should be recommended for use in relation to the field “device type”.  identity . For this purpose, the IC provided togeth er with the device should contain blank 
fields which shall be filled out by the health institution or healthcare provider, respectively. 
Since the establishment of (and the logistics behind) many different national IC designs is very 
expensive and of no additional benefit, Member States should ensure that, in the context of 
national implementation of Article 18 of the MD R, only the following information is required 
to be provided by the health institution or healthcare provider on the IC (together with the information provided by the manufacturer). Accordingly, a European or international 
blueprint for an IC which supports the purposes  described in Article 18, 2 should contain the 
following blank fields: 
1. Name of the patient or patient ID; 
2. Name and address of the health institution or healthcare provider who performed the 
implantation; 
3. Date of implantation. 
In order to be fit for the purposes described in Article 18, the outer dimensions of the IC should 
be the same as those of credit cards, ATM cards or ID cards (85.60 mm × 53.98 mm /3 3 ⁄8 × 
2 1⁄8  inches) and with a radius of 2.88–3.48 mm
3. 
4. Information to be provided by the  manufacturer on the Implant 
Card and information to be adde d by the health institution 
The manufacturer shall provide the following necessary information: 
1. Device name; 
2. Device type; 
3. Serial number or, where app licable, lot or batch number; 
4. Unique device identification (UDI); the UDI as AIDC4 format and the UDI-DI as HRI5 
5. Name and address of the manufacturer of the medical device; 
6. Website of the manufacturer of the medical device. 
The text provided on the IC and on the instru ction for completing the IC by the healthcare 
institution or healthcare provider must be legible and at least 2 millimetres high. ‘Text’ includes any: number, letter,  symbol, or  letter or number in a symbol.   
In addition, the manufacturer shou ld design the IC in a way that the following blank fields to 
be filled out by the implanting healthcare institution or healthcare provider are available: 
1. Name of the patient or patient ID; 
2. Name and address of the healthcare inst itution which performed the implantation; 
3. Date of implantation. 
  
                                                      
3 Dimensions to conform to the standard ISO/IEC 7810 ID-1.  
4 AIDC - Automatic identification and data capture format (e.g. linear or 2D-Barcodes)  
5 HRI - Human readable interpretation   5. Use of symbols 
To avoid national versions of the IC , the use of symbols is advisable.  
The following list contains symbols which have either been validated by users and have been 
submitted and accepted for inclusion in an upco ming international standard or already exist 
in the ISO database (Online Browsing Platform). The explanation of symbols on the IC should 
be provided in a leaflet (see section  7) or  on the back of the IC, if space allows. 
Article 18(1) lays down that the information provided in the IC shall be stated in the 
language(s) determined by the concerned Member State. 
List of symbols recommended for use on the IC6: 
 
 
  
 Patient Name or patient ID
 
 
 
 
 Date of implantation  
 
 
 
  Name and Address of the implanting healthcare 
institution/provide
r  
 
 
 
 Name and Address of the manufacturer  
 Information website for patients  
 Device Name7 
 
 Serial Number  
 
 
 Lot Number/Batch Code  
 
                                                      
6 The symbols for patient name or patient ID, name and ad dress of the implanting healthcare institution/provider, 
date of implantation, name and address of the manufacturer, serial number, lot number/batch code are already available and published in existing ISO standards. The symbols for device name, patient information website and 
UDI have been validated by users according to the ISO 15223-2 process. Note that the symbols listed here to indicate 
the following terms: ‘Device Name’, ‘Patient Name or Pati ent ID’, ‘Date of Implantation’, ‘Name and address of the 
implanting healthcare institution/provider’ on the implant card, are used in the ISO context to indicate ‘Medical Device’, ‘Patient Identification’, ‘Date’, ‘Health Care Center or Doctor’.   
7 Please note that in the ISO context, the ‘MD’ symbol is used to identify that the product in question is a medical 
device. On the implant card, this symbol is used to indicate the device name.  
 
 UDI as AIDC format  
UDI-DI information in a HRI format should  be introduced by the wording “UDI-DI”. 
6. Language requirements on specific fields 
Despite the nearly complete list of symbols for fields on the IC, there is currently no symbol 
available for the required field “Device Type”. 
The lack of a symbol and the purpose of this field makes it necessary that the information on 
the device type must be provided in the language accepted/required by the concerned 
Member State. 
There are several possibilities available to provid e this information in the necessary languages, 
e.g. the information is already printed on the IC in the different languages or stickers are 
provided with the IC and the healthcare professional selects the right one etc. 
7. Benefits of an informati ve instruction leaflet8 
As mentioned above (section 5), there is a need to provide, together with the IC, instructions 
on how to complete the IC and to explain the us ed symbols. This information shall be stated 
in the language(s) determined by the concerned Member State. For this reason, the use of a leaflet, containing the relevant information, to be provided together with the IC and the 
implantable device, is the recommended solution.  
As part of the risk management, the manufacturer has to investigate, by means of an 
ergonomic analysis or ergonomic usability test procedure, if the provided instructions are 
sufficient to enable the health professional to complete the IC correctly. The instructions must reflect the solution chosen by the manufacturer (e .g. pre-printed IC, blank IC with sticker(s) to 
be added, mixture of both). Special considerat ions might be needed when providing a system 
IC or an IC for a separate implantable compon ent, when there is not yet a common practice 
(standard) established.  
8. Implant Card for implantable systems 
If an implantable device contains implantable components which might be replaced by other 
(or the same) components, for example in case of a later revision, the manufacturers should 
consider the use of a System IC. In Annex I to this guide an example is provided. 
W a y s  c o u l d  b e  e x p l o r e d  b y  r e l e v a n t  s t a k e h o l d e r s  t o  d e v e l o p  c o m m o n  r u l e s  o n  h o w  t h e  
necessary information to be placed on the Sy stem IC is delivered with the replaceable 
component and how health professionals could en sure t hat  the  System  I C is  appropriately  
updated, when necessary. 
  
                                                      
8 This leaflet should not be confused with any possible vector of information referred to in points “b”, “c” and “d” 
of Article 18(1) of the MDR.  UDI Annex I examples of principle designs of Implant Cards and leaf lets 
 
GENERAL NOTE: All examples contained in this  Annex are to be intended as illustrative 
examples only.9  
The basic shape of the IC shall be designed in  compliance with ISO/IEC 7810 ID-1 (credit card 
form). 
The following pictures provide exam ples for individual device ICs.  
Example 1: 
 
Front – Not to scale (handwritten text on pre-printed content) 
 
 
 
 
 
 
 
 
 
Back – Not to scale (blank – serial printed content in 
production) 
 
 
 
 
  
                                                      
9 Please note that this includes translations (into languages other than English) shown in Examples 
throughout Annex 1, which are machine translated and not intended to be read as official translations 
into EU languages. International Implant Card 
https://www.genericmed.com/patientimplantinfo John Smith
27/05/2021
ABC Healthcare Center
123 Medical Parkway, Cork, Ireland
Dr. H.C. Professional
PM-5503  Pacer Advanced 
UDI-DI: (01)01865494261654  
SN79856214  
Genericmed 
500 Genericmed Place, Minneapolis, MN 55123 USA 
www.genericmed.com 
 
 
 
    Example 2: 
Back – Not to scale (blank – batch/lot printed content in 
production) 
 
 
 
 
 
 
 
 
 
 
 
  PM-5503  Pacer Advanced 
UDI-DI: (01)03584124658462  
Genericmed 
500 Genericmed Place, Minneapolis, MN 55123 USA 
www.genericmed.com AO.582122
Example 3 (suggested design of a foldable System IC): 
To be able to represent medical device syst ems in one IC, the IC shall be available in 
collapsible form.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
     ABC Healthcare CenterInternational Implant Card 
www.genericmed.com/patientimplantinfo John Smith 
27/05/2021 
123 Medical Parkway
Dr. H.C. Professional
Genericmed  
500 Genericmed Place,  
Minneapolis, MN 55123 USA 
www.genericmed.com  
Cork, Ireland PM-5503 
Pacer Advanced Pacemaker 
UDI-DI: (01)85412654285216 
SN65695452 
Genericmed  
500 Genericmed Place,  
Minneapolis, MN 55123 USA 
www.genericmed.com  PL-55-4 
Pacer Lead Pro Pacemaker Lead 
UDI-DI: (01)89654213882154 
SN86223214 
 
Examples of IC Leaflet  
Front 1 (no stickers – preferred option) 
 
Instruction for completion (to be provided in the language(s) determined by the concerned member State(s)) 
1. Name of the patient or patient ID. To be f illed by the healthcare institution/provider. 
2. Date of implantation. To be filled by  the healthcare institution/provider. 
3. Name and address of the healthcare institutio n/provider. To be filled by the healthcare 
institution/provider. 
 
   
 
 
  
PM-5503  
Pacer Advanced  
(01)8541265428
5216  
SN65695452 
Genericmed  
500 Genericmed Place,  
Minneapolis, MN 55123 www.genericmed.com/patientimplantinfo 
 
 
Front 2 (sticker only for device type information) 
 
Instruction for completion (to be provided in the language(s) determined by the concerned member State(s)) 
1. Name of the patient or patient ID. To be f illed by the healthcare institution/provider. 
2. Date of implantation. To be filled by  the healthcare institution/provider. 
3. Name and address of the healthcare instit ution. To be filled by the healthcare 
institution/provider. 
5. Add sticker with device type in required language. 
  
 
 
 
 
 
  
   
 
 
  
 
Stickers (to be detached and placed on the righ t place at the IC according to the numbers)  
 
  
PM-5503  
Pacer Advanced  
(01)85412654285216 
Genericmed  
500 Genericmed Place,  
Minneapolis, MN 55123 SN65695452 www.genericmed.com/patientimplantinfo 
5 
 
Front 3 (stickers)  
 
Instruction for completion (to be provided in the language(s) determined by the concerned member State(s)) 
1. Name of the patient or patient ID. To be f illed by the healthcare institution/provider. 
2. Date of implantation. To be filled by  the healthcare institution/provider. 
3. Name and address of the healthcare institutio n/provider. To be filled by the healthcare 
institution/provider. 
4. Manufacturer’s information website.  
5. Device type in required language.  
6. Device name.  
7. UDI-DI Code (HRI). 
8. UDI code (AIDC format). 
9. Serial number. 
10. Name and address of the 
manufacturer of the implanted 
medical device.  
 
NOTE: Fields 4-10 might be filled 
with stickers (though this is not the 
preferred solution) 
  
 
 
  
 
 
Stickers (to be detached and plac ed on the right place at the IC  according to the numbers)  
5, 6 
 
9 
 
    8           
 
 7 2 081019001 002 4  
10 
 
4 
 
Back  
 Explanation/ transl ation of symbols 
 Patient Name or patient ID, Име на пациента , Jméno pacienta, Patientens navn, 
Patientenname, Όνομα ασθενούς , Nombre del paciente, Patsiendi nimi, Potilaan nimi, 
Nom du patient, Ime i prezime bolesnika, Imi ę i nazwisko pacjenta, A beteg neve, 
Nome del paziente, Paciento vardas ir pavard ė, Pacienta v ārds, uzvārds, Naam patiënt  
Pasientens navn, A beteg neve, Nome do doente, Nume pacient, Meno pacienta, Ime bolnika, Patientens namn 
 Name and Address of the implanting healthcare institution/provide r , établissement 
sanitaire, centro de salud, struttura sanitaria, Gesundheitseinrichtung, 
gezondheidszorginstelling, placówka słu żby zdrowia, здравно  заведение, veselības 
aprūpes iestāde, εγκατάσταση για την υγεία  
 Date of Implantation , Дата  на имплантиране, Datum implantace, Implanteringsdato, 
Implantationsdatum, Ημερομηνία  εμφύτευσης,  
Fecha de implantación, Implanteerimiskuupäev, Implantointipäivämäärä, Date d’implantation, Datum implantacije, Beültetés dátuma, Data dell'impianto, Implantavimo data, Implant ēšanas datums, 
Implantatiedatum, Data wszczepienia , Data do implante, Data implant ării, Dátum 
implantácie, Datum vsaditve 
 Device Name, Nazwa urz ądzenia medy 
cznego, Název zdravotnických prost ředků, Medicinsk enhed, Name des 
Medizinprodukts, Nombre del dispositivo médico, Nom du dispositif médical, Orvosi eszköz neve, Namn på medicinsk enhet, Ime medicinske naprave Nome do dispositivo médico 
 κατασκευαστής, Producent, Fabrikant, Produttore, Fabricante, Fa bricant, manufacturer, 
Hersteller  
 Information website for patients , Webová stránka s informacemi pro pacienta, 
Informationswebsite for patienten, Webseite mit Informationen für Patienten, Sitio web 
con información para el paciente, Site d'in formations pour le patient, Információs 
honlap betegek számára, Sito web con le informazioni per i pazienti, Website met informatie voor patiënten, Strona internetowa z informacjami dla pacjenta 
 
 Translation of serial number in required languages. 
 
 Translation of LOT number in required languages. 
 Explanation of unique device identi fier (UDI) in required languages. 
 
 
Place to attach the  
Implant card