Medical Device       
Medical Device  Coordination Group Document   MDCG  201 9-5   
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MDCG  201 9-5 
 Registration of legacy devices in EUDAMED  
               
 
 April  2019  
 
 
  
 
 
 
 
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 regar ded 
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.  
 
  Medical Device       
Medical Device  Coordination Group Document   MDCG  201 9-5   
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This document deals with registration of devices, which can continue to be placed on 
the market under Directive certificates by virtue of Article 120(3) of Regulation 
745/2017 (MDR), and Article 110(3) of Regulation 746/2017 (IVDR) after the relevant 
MDRs application dates. Those products are, for the purpose of this document, 
referred to as “legacy devices”1. All following considerations, which are made in 
relation to the MDR shall apply to the IVDR, mutatis mutandis.  
Art 120(3) of the MDR lays down that t he requirements of the MDR relating to post -
market surveillance, market surveillance, vigilance, registration of economic 
operators and of devices shall apply to legacy devices placed on the market after the 
application date of the MDR in place of the corr esponding requirements of the 
Directives.   
The MDR is not explicit in requiring that these “legacy devices” are subject to relevant 
UDI obligations. The MDR device registration requirements (Annex VI Part A Section 
2 and Part B that are complementary) mak e the Basic UDI -DI and UDI -DI the access 
keys for device -related information in the future Eudamed, which is reflected in the 
database design. Therefore, any registration of a device is normally possible in 
Eudamed only if a proper Basic UDI -DI and UDI -DI are assigned to the device and 
registered in the database together with the other device -related data.   
 
In light of this, taking all views heard into account, and considering that Article 120(3):  
- Refers to legacy devices to be registered in line with MDR  provisions,  
- Lacks any explicit reference to UDI obligations for legacy devices   
the MDCG considers it appropriate to adapt the Eudamed design to allow the 
registration of legacy devices in Eudamed in the absence of a (Basic) UDI -DI.  
This is intended to prevent any technical constraint to the applicability of Art 120(3) 
for legacy device registration in Eudamed.  
A comprehensive description of the technical implications is provided in the Annex.   
                                                           
1 It shall be noted  that, in other contexts, the term “legacy devices” might be used with a different meaning.  Medical Device       
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Annex  
Basic considerations related to functioning of future registration of legacy 
devices in Eudamed  
1. Legacy devices – covered by a valid Directive certificate - that will continue to 
be placed on the market after the MDR date of application should be 
registere d in Eudamed without a Basic UDI -DI and UDI -DI. The registration 
deadlines for those devices is clearly the one referred to in Article 123(3)(e):  
18 months after the date of application (provided that Eudamed is fully 
functional on time)2.  
2. However, in ca se of serious incident or field safety corrective action to be 
reported during the 18 months referred to in point 1, where the legacy devices 
have not been registered in Eudamed yet, they must be registered at the 
moment of the serious incident/field safet y corrective action reporting.   
3. Point 1 will be applicable only to the devices that are not already registered as 
MDR devices.  
NOTE: All the Directive -compliant devices which have been placed on the market 
ahead of the general application dates and will not continue to be placed on the 
market afterwards, should be registered in Eudamed (without a Basic UDI -DI and 
UDI-DI) only if a serious incident report and/or a field safety corrective action report 
(with the field safety notice) occurs after the applica tion date.  
 
 
Technical implementation in Eudamed  
4. Legacy devices that will be registered in Eudamed will need two other 
unique access keys (IDs) to replace the Basic UDI -DI and UDI -DI for the 
sake of the workability of Eudamed .  
5. For this purpose, a Eudamed DI will be assigned to the device instead of the 
Basic UDI -DI and a Eudamed ID will be assigned by Eudamed instead of the 
UDI-DI allowing the system to work and to keep the design of Eudamed as 
close as possible to the MDR design. These Eudamed DI and Eudamed ID will 
be unique for a given legacy device.  
6. The Eudamed DI could be either entirely generated by Eudamed or the 
manufacturer could partly assign the DI code. On the other hand, the 
Eudamed ID will be always automatically and fully generated b y Eudamed  
                                                           
2  It should be noted that all class I devices that are not sterile and/or with a measuring function under the 
Directives, are not eligible for any grace period. When placed on the market after the MDR date of 
application, they will have to be MDR compliant and be registered in EUDAMED  as MDR devices.   Medical Device       
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from the Eudamed DI. The proposed rules for the assignment (still under 
discussion) are that Eudamed DI start with character "B", where Eudamed ID 
will start with character "D" (only difference between Eudamed DI and 
Eudamed ID). Beside this f irst character, the Eudamed DI/ID will include the 
SRN of the manufacturer, a number (assigned by the manufacturer or 
Eudamed) and a check digit.  
7. The relationship between the Eudamed DI and a Eudamed ID will be one to 
one.  
8. Furthermore, the registration o f the legacy devices will require the 
manufacturer to enter the directive certificate identification (NB number, 
certificate number, revision number and expiry date) since they will not be 
registered in Eudamed by the NBs.  
In case a legacy device has been already registered in Eudamed and that same 
device becomes at any point in time an MDR compliant device, that MDR device 
should be considered as a new device requiring a new registration (due to the 
change in the applicable  legislation) with a Basic UDI -DI and UDI -DI in Eudamed. 
However, only a UDI -DI should be entered, if another device with the same Basic 
UDI-DI has already been registered. Eudamed should facilitate this (copy) process 
and allow the linking between the  MDR  device and the corresponding legacy device .