Medical Device       
Medical Device  Coordination Group Document   MDCG  201 9-4   
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MDCG  201 9-4 
Timelines for registration of device  
 data elements 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 docum ent 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.  
 Medical Device       
Medical Device  Coordination Group Document   MDCG  201 9-4   
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“With regard to timelines for device registration, the text of the MDR presents an 
inconsistency. On the one hand, Article 123(3)(d) lists the full Article 29 as being 
applicable from the application dates or, if EUDAMED is not functional on time, six 
mont hs after the date of publication of the notice referred to in Article 34(3). On the 
other hand, Article 123(3)(e) grants an additional 18 -month transitional period for 
obligations contained in Article 29(4).  
Taking into account:  
- the declared will of the c o-legislator to grant an 18 -month additional 
transitional period for device registration and registration of certificates,  
- the logical correspondence and complementary character of device data 
elements in Part A (Section 2) and Part B of Annex VI,  
- the nee d to ensure that information on devices in EUDAMED is not displayed 
to public in a partial or misleading nature,  
the obligation for registration in EUDAMED of device data elements listed in 
both part A, Section 2, and Part B of Annex VI, shall be applicabl e as from the 
timelines indicated in Article 123(3)(e) (meaning from 18 months after the 
general application date or, if EUDAMED is not fully functional on time, from 24 
months after the date of publication of the notice referred to in Article 34(3)).  
This is without prejudice to the fact that the obligation related to the operation of 
assignment of Basic UDI —DI and UDI -DI to devices remains applicable as from the 
general application dates.  
This is also without prejudice to the fact that at any time after the general application 
date, for MDR compliant devices, the full registration of devices (Article 29) remains a 
pre-condition for the possible registration of their relevant serious incident in 
EUDAMED  
These considerations apply mutatis mutandis  to the IV DR”.