1 
 Medical Device       
Medical Device Coordination Group Document    MDCG 2020 - 3    
 
 
 
       
   MDCG 2020 -3 
Guidance on significant changes regarding  
   the transitional provision under Article 120  
       of the MDR with regard to devices covered  
       by certificates according to MDD or AIMDD            
 
             March 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 ca nnot 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. 
 
    
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Guidance on  significant changes  regarding the 
transitional provision under Article 120 of the 
MDR with regard to devices covered by 
certificates  according to MDD or AIMDD1 
 
1 Introduction  
Article 120( 2) and 120( 3) of the  Medical Device Regulation  (EU) 2017/745 (MDR) states that 
devices which  have a valid certif icate issued by a notified body under the Active Implantable 
Medical Devices Directive 90/385/EEC  (AIMDD) or the Medical Devices Directive 9 3/42/EEC 
(MDD) may be placed on the market or put into service after th e date of application of the MDR 
under certain conditions  and no later than  26 May 2024.  
Questions 8 and 9 of the CAMD Transition Sub Group  guidance : “FAQ – MDR Transitional 
provisions, V1.0 of 17. January 2018”2 state that the certificates  covered by MDR Article 120(3) 
include “all certificates which are commonly issued by notified bodies with reference to the 
Council Directives MDD and AIMDD” . 
Conditions referred to in the first paragraph require that no  significant change s in design or 
intended purpose  of a device  be performed  after the date of application of the MDR . Therefore, it 
is important for manufacturers and notified bodies to get clarity on the significant changes to be 
considered under  MDR Art icle 120(3).  
It is also important that the AIMDD and MDD certificates remain valid following changes that are 
not significant with regard  to design or intended purpose , provided that the required surveillance 
is carried out  by the notified body that issued the certificate. See also Question 17 of the above 
mentioned CAMD guidance2. 
2 Scope  
This guidance document is intended to provide clarification on the changes to a device that 
should be considered a “significant change in design or a significant change in the intended 
purpose” under  MDR Art icle 120(3). Assessment s should  be made on a case -by-case basis.  
                                                           
1 The principles  outlined in this guidance can be applied also for class I devices requiring the involvement of a 
notified body for the first time.  
2 https://www.camd -europe.eu/wp -content/uploads/2018/05/FAQ_MDR_180117_V1.0 -1.pdf    
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 This guidance document does not elaborate on the process for manufacturers’ submission and  
notified bodies’  assessment of such changes as these should be part of the conformity 
assessment process  and surveillance  defined by the relevant notified body under the MDD or 
AIMDD. It is expected that manufacturers adjust their change not ification procedures, i.e. their 
provisions to inform their notified body on changes, in accordance with the principles outlined in 
this guidance until the date of application of the MDR. The adjusted procedures will be subject to 
notified body assessment within their surveillance activities according to MDR Art. 120(3).   
3 Changes to Directive  certificate s 
It is important to highlight that no issuing of new MDD/AIMDD certificates, including modified,  
amended  or supplemented certificates , is allowed under MDR Article 120(3).  In particular, i f the 
manufacturer wishes to make a  “significant chang e in design or intended purpose” under MDR 
Article 120(3), the implementation of such a  change would  prevent the manufacturer from 
continuing to place that device on the market  under the Directives . 
4 Assessment of changes' significance  in accordance with MDR 
Article 120(3)  
In line with agreed arrangements for notification of changes between the manufacturer and the 
notified body  according to the AIMDD/MDD  (e.g. contractual relationships, approved  procedures)  
changes and their implementation will be verified by the notified body as part of the surveillance 
activities, or following a manufacturer’s  submission for prior approval . The outcome of this 
verification will determine whether a certificate in accordance with AIMDD/MDD remains valid 
according to Article 120 MDR. To use this derogation from Article 5 MDR manufacturers are not 
allowed to make s ignificant change s in design or a significant changes in the intended purpose. 
In case of doubt whether a change is significant they should ask their notified body .  
For instance, administrative changes of organisations are considered in principle as non -
significant. This includes changes of the manufacturer’s name , address or legal form  (legal entity 
remains) or changes of the authorised representative.  
Furthermore, all changes not having an impact on the design or the intended purpose of the 
device can be regarded as not significant  in the meaning of MDR Article 120(3) .  This is the case 
for example of relocation or addition of new manufacturing sites, including when it affects 
subcontractors  or suppliers , or of certain changes of the quality management system, provided 
that the conditions for which the conformity assessment certification was granted are maintained. 
Nevertheless, such changes continue to be subject to the agreed notification procedure identified 
in the first paragraph of the current secti on. T he manufacturer should always remain responsible 
for providing evidence that all the above -mentioned changes do indeed neither  affect the design 
nor the intended purpose.     
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 On the other hand, when the change is likely to affect the design or the inten ded purpose of the 
device, the significance of such a change must be assessed on a case -by-case basis.  
To facilitate a harmonised judgement of the significance of changes flowcharts (see Annex) have 
been developed.  
If a change is not a significant chang e in design or intended purpose  under MDR Article 120(3), 
the implementation of such a change  is therefore  allowed during the transitional period. Acc. to 
section 3 the certificate should not be amended.  
The notified body that issued the AIMDD or MDD certif icate may confirm in writing (after having 
reviewed manufacturer’s description of the (proposed ) change) that the implementation of the 
change does not represent a significant change in design or intended purpose under MDR Article 
120(3) and that the relat ed AIMDD or MDD certificate remains valid after the date of application 
of the MDR, but no longer than its expiry date or 26 May 2024, whichever comes first. Such 
written confirmation corrects or complements information on an existing certificate but does not 
represent the issuance of a “supp lemented certificate” as this is prohibited as mentioned in 
Section 3 . In case of requests from authorities the manufacturer should number such letters 
received from the notified body and submit them together with the certificate.   
In relation to class I medical devices requiring the involvement of a notified body for the first time, 
manufacturers of such devices must be able to justify their decision when the changes are 
considered to be non -significant. The justificat ion shall be documented and made available when 
requested.  
This guidance document provides in its Annex several flowcharts based on NBOG’s Best 
Practice Guide 2014 -3: “Guidance for manufacturers and Notified Bodies on reporting of Design 
Changes and Change s of the Quality System” . In particular, Chart C , which is specific to 
software, draws inspiration  from Annex VI, Part C, section  6.5 of the MDR to identify 
modifications that are considered as significant change in (software) design.  
The assessment of a proposed change by using the main flowchart and any of the applicable  
sub-charts in the Annex, is intended to assist  manufacturers and notified bodies  in deciding  
whether or not a change is to be considered significant in the design or intended purpose of the 
device under MDR Art icle 120(3).  
The flowcharts are divided into a main chart and five sub -charts (A to E) . There are six 
categorical questions in the main chart that are linked to  one or more sub -charts with more 
detailed questions . The change is considered a non -significant change of design or intended 
purpose per MDR Art icle 120(3)  if the answer to every  question in a sub -chart leads to “ non-
significant change ” also when returnin g to the main chart. On the contrary, if any  sub-chart   
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 delivers the result “significant change” , the change being assessed is a “ significant chang e in 
design or intended purpose”  of a device according to the MDR Article 120(3).  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
   
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 Annex  
Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
     Main Chart   
Change of an existing Medical Device  
certified under MDD or AIMDD  
Change of the  
Intended Purpose?  
Software change?  
Chart A  
Chart B  
Chart C  
Yes  
Yes  
Yes  
No 
No 
If non -significant  
If non -significant  
If non -significant  
A 
B 
C 
Change of the  
design or  
performance  
specification?  
No 
No 
X 
Design change related  
to corrective  
actions*?  
*assessed and  
accepted by the  
relevant Competent  
Authority acc. to  
CAMD FAQ no 17  
Yes    
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 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
Main Chart (ctd.)  
 
 
 
 
 
 
 
 
Change of a  
Material*?  
Change  
of terminal  
sterilization method of  
device or packaging design  
with impact to the  
sterilisation?  
Chart D  
Chart E  
The change is considered a  
non 
- 
significant change  
per MDR Art. 120(3)  
Yes  
Yes  
No 
No 
No 
If non -significant  
D 
E 
*The termmaterial  
includesany  
substance  
( 
synthetic, natural,  
biological, chemical,  
physical, medicinal,  
...) 
 that is used to  
make or compose  
the device    
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 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
Chart A  
 
FromMain  Chart:  
Change of the IntendedPurpose*  
The changeisconsidered  
significantper MDR Art. 120(3)  
Extension  
or change of the  
Intended Purpose?  
New user or  
patient population?  
Change of  
clinical use**?  
Yes  
Yes  
Yes  
No 
No 
No 
Limitation of the  
Intended  
Purpose?  
Return toMain Chart  
QuestionX  
Yes  
No 
A1 
A2 
A3 
A4 
** Example:  
- 
Change in the  
anatomical site;  
- 
Change in the access  
site or deployment  
methods;  
*  Labellingchangesshouldbe  
assessedtoensuretheyarenot  
potentiallysignificantwhen  
linkedtothe intendeduse(e.g.  
contraindicationsandwarnings).   
 
 
 
 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
 
Chart B  
 
 
FromMain Chart:  
Change of theDesignorPerformance Specification*  
Yes  
No 
No 
B1 
Change  
of built -in control  
mechanism, operating  
principles, source  
of energyor  
alarms  
? 
Yes  
No 
Return toMain Chart  
QuestionC (or move directly to E  
if Chart D was previously used)  
Yes 
B3 
The changeisconsidered  
significantper MDR Art. 120(3)  
betakeninto  
 not 
 * Itshall  
accounthowthe changeis  
achieved. A changein specification  
maybetriggeredby, but isnot  
limited to, changeof hardwareor  
software, includingchangeof a  
component.  
Does the  
change require  
further clinical or  
usability data to support  
safety and perfor - 
mance?  
** 
Do new risks  
require control measures  
or are existing risks  
negatively  
affected?  
B2 
** Compare  
MEDDEV 2.7/1 rev.4  
forfurtherguidance   
 
 
 
 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
Chart C  
 
 
 
 
 
FromMain Chart:  
Software Change  
New or modified  
architecture or database  
structure, change of  
an algorithm?  
Required  
user input replaced  
by closed loop  
algorithm  
? 
Yes  
Yes  
No 
No 
New or major  
change of operating  
system or any  
component?  
No 
Yes  
C1 
C2 
C3 
New diagnostic or  
therapeutic feature,  
or new channel of  
inter-operability  
? 
Yes 
C4 
No  
 
 
 
 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
 
Chart C (ctd.)  
 
 
 
 
The changeisconsidered  
significantper MDR Art. 120(3)  
Yes 
No 
Return toMain Chart  
QuestionD  
C5 
No 
New user interface or  
presentation of data*?  
*“Presentationof data“  
goesbeyondthe  
appearanceof theuser - 
interface whichmayinclude  
newlanguages, layoutsor  
graphicsandisconsidered  
a minor change.  
Itisconnectedtomedical  
datawhicharepresentedin  
a newformatorby a new  
dimensionormeasuring  
unit.  
Yes 
*Minor changeswithout  
impacttodiagnosisor  
treatmentdeliveredmay  
include:  
- 
correctionof an error  
whichdoesnot posea  
safetyrisk(bugfixes),  
- 
Security update (e.g.  
cyber -security  
enhancements,  
longevitycalculations),  
- 
appearanceof the user  
interface,  
- 
operatingeffeciencies.  
- 
Changestoenhancethe  
userinterfacewithout  
changesin performance  
Minor Change*?  
C6  
 
 
 
 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
 
Chart D  
 
 
 
 
 
 
FromMain Chart:  
Change of a Material*  
Change to a  
material of human/animal  
origin including addition of  
new materials?  
No 
Yes  
Change  
to a material  
containing a MS**  
ortothe MS  
itselfor, a change which may  
impact the quality, safety or  
efficacy of a MS  
*** 
? 
Yes  
No 
D1 
D2 
**MS: Substancewhich,  
if used separately, would  
be considered to be a  
medicinal substance  
***Including a change in  
its manufacturing process,  
which result in changes to  
the existing specification  
of the medicinal  
substance.  
* These relate to changes  
involving existing  
ingredients and materials.   
 
 
 
 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
 
Chart D (ctd.)  
 
 
 
 
 
Ingredient  
new 
 ormaterial from  
uppliermeetsexisting  
 s 
specification?  
The changeisconsidered  
significantper MDR Art. 120(3)  
No 
Yes  
Yes 
Changed  
ingredientor  
material fromexisting  
suppliermeetsexisting  
specification?  
No 
Return toMain Chart  
QuestionE  
D3 
D4 
Change tobeassessedin  
accwithChart B   
 
 
 
 Design Changes and Changes of the Intended Purpose  
Which may be Considered “Significant“ When Interpreting the 
First Sentence of MDR Art. 120(3)   
Chart E  
 
 
FromMain Chart:  
Change of terminal sterilization method  
of device or packaging design  
with impact to the sterilization  
Design Change  
which affects or  
changes the sterility  
assurance**?  
Yes  
No 
No 
Yes  
Change in  
packaging design which  
affects functionality, safety,  
stability or  
seal integrity?  
E2 
E3 
Shelf-life change  
validated by protocols  
approved by the notified body  
***? 
The changeisconsidered  
significantper MDR Art. 120(3)  
The change is considered a  
non-significant change  
per MDR Art. 120(3)  
No 
 Yes  
E4 
** Guidance on assessing  
changes for their impact on  
the effectiveness of the  
sterilization process is  
provided in the respective  
sterilization standards such  
as: 
 
EN ISO 11135 (Ethylene  
Oxide),  
 
EN ISO 11137 -1  
Radiation),  
 ( 
 
EN ISO 17665 -1 (Moist  
Heat),  
 
EN ISO 13408 -1 (Aseptic  
Process).  
Change* of  
terminal sterilization  
method?  
No 
Yes  
E1 
* Includes change from  
non-sterile to sterile or a  
change to the sterilisation  
method. Changes of cycle  
parameters under the  
approved quality  
management system are  
not deemed as significant in  
the meaning of Art. 120(3)  
MDR  
***In principle, an increase  
in shelf life can be  
considered non -significant  
( 
e.g. the increase is made  
following the completion of  
a real time test whose  
method and end -point was  
validated and previously  
assessed by the notified  
body).