Medical Devices       
Medical Device  Coordination Group Document   MDCG  201 9-3 Rev.1   
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MDCG  2019 -3 Rev. 1 
 Interpretation of Article 54(2)b     
          
 
 
 April 2020  
 
 
  
 
 
 
 
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 Devices       
Medical Device  Coordination Group Document   MDCG  201 9-3 Rev.1   
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MDCG 2019 -3 Rev. 1 changes  
Addendum on procedural aspects  New 
 
 
Interpretation of Article 54(2)b  
Article 54(2) of the MDR lays down three criteria that exempt devices from the pre -
market clinical evaluation consultation procedure with the involvement of expert 
panels. In particular that article states that:  
“The procedure referred to in paragraph 1 shall not be required for the devices 
referred to therein:  
(a)  in the case of renewal of a certificate issued under this Regulation;  
(b)  where the device has been designed by modifying a device already marketed by 
the same manufacturer for the same intended purpose, provided that the 
manufacturer has demonstrated to the satisfaction of the notified body that the 
modifications do not ad versely affect the benefit -risk ratio of the device; or  
(c) where the principles of the clinical evaluation of the device type or category have 
been addressed in a CS referred to in Article 9 and the notified body confirms that the 
clinical evaluation of the manufacturer for this device is in compliance with the 
relevant CS for clinical evaluation of that kind of device”.  
Interpretation of point (b) of Article 54(2) is unclear, notably in relation to the 
application of the word “marketed”.  In fact, while in point “a” the co -legislator 
explicitly indicates that the certificates referred to are those issued under the new 
Regulation, in point “b” there is no indication of whether a “device already marketed” 
refers to devices already marketed under the Directi ves or the Regulations.  
This has raised questions from the public and from Member States.  
As we are about to launch the procedures for the establishment of expert panels, 
clarification of this issue is extremely urgent, notably due to its impact on the fu ture 
workload of panels and hence on relevant budget and workload estimations.  
The following considerations seem to indicate that the expression “device already 
marketed” cannot be intended to refer to a device already marketed uniquely under 
the new Regu lation : 
 If the co -legislators had decided to restrict the application of point “b” to devices 
marketed uniquely under the MDR, they would have explicitly stated so, as they 
did for point “a”;  
 Article 54, together with other Articles (such as Article 61(6) and Article 120(3)), 
was written at the end of the negotiation process with a view to smoothen the  Medical Devices       
Medical Device  Coordination Group Document   MDCG  201 9-3 Rev.1   
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implementation of the new Regulation. Therefore the interpretation of the 
exemption should be understood in line with the spirit and intention of the co -
legislators.  
 
It has to be noted that, in respect to devices that have been marketed already under 
the relevant Directives, the word “modification” shall be meant as limited only to those 
modifications needed in order to comply with the new legal requiremen ts introduced 
by the MDR1 2. 
 
 
Addendum - Procedural aspects  
 
Together with the application to be lodged under the applicable conformity 
assessment procedure, the manufacturer will provide the notified body with:  
 a statement that it has marketed the device  in question for the same intended 
purpose under the relevant Directive,  
 copy of the last issued certificate(s) together with the certificate history, and  
 a description of the modifications introduced to comply with the MDR  
As part of its technical documen tation assessment according to the MDR, the notified 
body will verify that the “modifications”, as referred to in the main document, do not 
adversely affect the benefit -risk ratio. In particular, the notified body will verify:  
 that the device in question h ad a valid certificate under the Directives,  
 in case the certificate has been withdrawn, suspended3 or expired, if there is 
an impact on compliance with the general safety and performance 
requirements, and  
 that there is no pending assessment of changes fo r the device or outstanding 
non-compliance.   
In addition, the notified body will verify the description of modifications provided and 
assess if these modifications are limited only to those needed in order to comply with 
the new legal requirements introdu ced by the MDR. Limitations of the intended 
purpose of the device should not trigger the consultation procedure in accordance to 
Art. 54.  
                                                            
1  These devices will anyhow be subject to all applicable new MDR requirements, including those ones related 
to the clinical evaluation, and will need to be assessed by notified bodies against these new (and higher) 
requirements. This aspect together with the increased notified bodies’ oversight foreseen under MDR should 
guarantee a high standard of safety for these products.  
2  From a practical perspective, u nder the scenario where those products had to be subject to clinical evaluation 
consultation procedure with the involvement of expert panels, as a result of the application of criteria set in 
Annex IX 5c, in most if not all of the cases, the panel would de cide not to give an opinion. Therefore , a very 
significant additional workload and financial burden would be created for an extremely limited added value.  
3    Certificates for which the rationale for withdrawal or suspension is linked to lack of complian ce with essential   
requirements may adversely affect the benefit -risk ratio of the device and will require a clinical evaluation 
consultation procedure.  Medical Devices       
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In case that any of the abovementioned conditions are not fulfilled the notified body 
will follow the consultation procedure in accordance to Art. 54.  
The assessment of the above conditions will be documented by the notified body in 
accordance with Section 4.6 of Annex VII in the clinical evaluation assessment report 
that will be made available to competent authorities  in accordance with Art. 54 (1) 
and (3).  
 
 
Clarifications in respect to the applicability of Art. 54(2)b with regard to devices 
already marketed under the MDR are to be provided in a separate guidance.