Medical Device       
Medical Device  Coordination Group Document   MDCG  201 9-10 rev.1   
Page 1 of 2 
  
 
 
 
 
MDCG  201 9-10 rev. 1  
 Application of transitional provisions concerning     
 validity of certificates issued in accordance to 
 Directives 90/385/EEC and 93/42/EEC     
            
 
 October  2019   
 July 2020 rev. 1 
 
 
  
 
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.  
 
  Medical Device       
Medical Device  Coordination Group Document   MDCG  201 9-10 rev.1   
Page 2 of 2 
  
MDCG 2019 -10 revision 1 changes  
MDR postponement dates: from 2020 to 2021  
Application of transitional provisions concerning validity 
of certificates issued in accordance to Directives 
90/385/EEC and 93/42/EEC1 
According to Article 120(2) of Regulation (EU) 2017/475 on Medical Devices (the MDR), certificates 
issued in accordance with Directives 90/385/EEC and 93/42/EEC  (the Directives ) will remain valid 
until 26 May 2024 at the latest. However, Article 120(3) establishes specific conditions that such 
certificates, and the related devices thereof, have to comply with.  In particular, it is required that the  
notified body that issued the certificate – under a valid designation – continues to be responsible for 
the appropriate surveillance activities with respect to all of the applicable requirements related to 
the devices it has certified and that it has the possibility to take any necessary measure in relation to 
those. 
It has to be noted that, as reported in FAQ n.17 of the MDR transitional provision document 
published by the  CAMD Transition Sub Group, the contract between the manufacturer and the 
notified body who issued the certificate under the relevant Directive  shall include provisions allowing 
the appropriate performance of such surveillance activities.  
In order to allow manufacturers to take advantage of Art. 120( 2) and Art. 120(3) of the MDR, it needs 
to be ensured that Authorities  responsible for notified bo dies have the right to and do monitor those 
notified body’s activities to the extent appropriate and necessary. For this purpose, Article 120(3) 
and Article 122(1) of the MDR provide the necessary legal basis for Member States to establish the 
necessary le gal empowerments2 by means of National law to carry out the needed  monitoring 
activities in relation to Notified Bodies. All this is regardless of whether the Notified Body has applied 
or not to be designated under the MDR  and/or it has a still valid desig nation under the Directives 
during the validity of certificates issued in accordance to the Directives . 
Concerning information published in the NANDO database, in accordance to Article 120(1) of the 
MDR, any publication of a notification in respect of a no tified body in accordance with the Directives 
will become void  as from 26 May 2021 .  Therefore, NANDO will only be used in relation to the  
Directives for information purposes after 25 May 2021 . NANDO will therefore list those notified 
bodies  that have bee n designated under the Directives with a clear  message that they are not able to 
issue new certificates but only  allowed to carry out  surveillance activities for valid certificates in the 
transitional period, as established in  Article 120 of the MDR.  
                                                           
1  This document specifically refers to transitional provisions laid down in Regulation (EU) 2017/745  but can 
be applied by analogy to Regulation (EU) 2017/746.  
2  It should be noted that  relevant legal empowerments might be already available by means of National law 
which build on different EU pieces of legislation.