Medical Device       
Medical Device Coordination Group Document                          MDCG 2020 -2 rev.1  
 
 
 
 
     MDCG  2020 -2 rev. 1  
       Class I Transitional provisions under  Article      
      120 (3 and 4) – (MDR)             
 
             March 2020  
         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 2020 -2 rev.1  
 
MDCG 2020 -2 revision 1 changes  
MDR postponement dates  : from 2020 to 2021  
How can a ffected manufacturers of some class I devices1 make efficient 
use of the transitional provisions in A rticle 120 (3 ) and (4) of Regulation 
(EU) 2017/745 – Medical Devices Regulation ( MDR )? 
Background:  
The corrected MDR2 Article 120 (3) allows  under certain condition s, some class I devices pursuant to 
Directive 93/42/EEC  – Medical Devices Directive (MDD) , for which the Declaration of C onformity 
was drawn up prior to 26 May 2021 and for which the conformity assessment procedure pursuant to 
the MDR would require the involvement of a notified body,  to be placed on the market3 until 2 6 May 
20244.  
In order  to make use of this article , the following conditions must be met:  
1. The device continues to comply with Directive 93/42/EEC,  
2. A notified body will need to be involved under the MDR (e.g. re -usable surgical instruments 
or up -classified devices)  
3. A valid Declaration of C onformity , according to Annex VII  of the MDD , must be drawn up 
befor e 26 May 2021,  
4. No significant changes to the design or intended purpose of the device  after 26 May 202 15, 
5. The requirements of the MDR relating to post -market surveillance, market surveillance, 
vigilance, registration of economic operators and of devices shall apply in place of the 
corresponding  requirements in Directive 93/42/EEC .6 This shall be in place on the 26 May 
2021. 
 
Scope  
The scope of this document is to provide guidance related to the information to be provided in the 
form of a  Declaration of Conformity by manufacturers of Class I devices  (devices which are non -
                                                           
1 Class I devices for which the conformity assessment procedure pursuant to the MDR would require the involvement of a 
notified body.  
2 Corrigendum to Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical 
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing 
Council Directives 90/385/E EC and 93/42/EEC (OJ L 117, 5.5.2017), of 27.12.2019.  
3 Devices which are not placed on the market but put into service may also make use of the transitional provisions .  
4 Article 120(4) ‘and may continue to be made available on the market …until 26  May 2025’ . 
5 Guidance on significant changes under Article 120 of the MDR with regard to devices covered by certificates according to 
MDD or AIMDD . 
6 Upcoming guidance on harmonised practices and technical solutions  to facilitate exchange of information in absence of 
EUDAMED .  Medical Device       
Medical Device Coordination Group Document                          MDCG 2020 -2 rev.1  
 
sterile or do not have a measuring function) that are required to have certificates after 26 May 2024 
according to the MDR.  
Content of a val id Declaration of Conformity  
The manufacturer or his authorised representative established in the European Union is  obliged to 
issue a  Declaration of Conformity  that the  product has undergone  a conformity assessment  procedure 
required by the MDD  before being placed on the market.   
 
With the Declaration of Conformity, the manufacturer declares that the products concerned meet the 
relevant provisions of the MDD.  
MDD Annex II, Annex V, Annex VI set out that a Declaration of Conformity must cover one or more 
medical devices manufactured  7 clearly identified by means of product name, product code or other 
unambiguous reference for class IIa, IIb and III devices, and also class Im and class Is devices. This is 
however not necessary for  other  Class I devices, as it is not required by the MD D (Annex VII) and as 
there is no certificate from a notified body to which the issued Declaration of Conformity is related.  
Guidance on  the content of the Declaration of C onformity can be found, inter alia, in the “The ‘Blue 
Guide’ on the implementa tion of EU products rules 2016 (2016/C272/01) ”8 and the  standard EN 
ISO/IEC 17050 -1.9 According to this standard , the declaration may take the form of a document or any 
other suitable medium , and should contain sufficient information to enable all products  covered to be 
traced back to it.  The model declaration in Annex III of Decision No 768/2008/EC  and the ‘Blue 
Guide’  on the implementation of EU products rules 2016 (2016/C272/0 1) describe the content of the 
Declaration of C onformity to be as follows:   
1.  A number identifying the product. This number does not need to be unique to each product. It 
could refer to a product, batch, type or a serial number .10 This is left to the discretion of the 
manufacturer .11   
2.  The name and address of the manufacturer or  the authorised representative issuing the 
declaration.  
3.  A statement that the declaration is issued under the sole responsibility of the manufacturer.  
                                                           
7 MDD Annex II, paragraph 2  ‘This declaration must cover one or more medical devices manufactured, clearly identified by 
means of product name, product code or other unambiguous reference and must be kept by the manufacturer.’  
8 https://eur -lex.europa.eu/legal -content/GA/TXT/?uri=CELEX:52016XC0726(02) . 
9 EN ISO/IEC 17050 -1 : 2004 Conf ormity assessment – Supplier’s D eclaration of Conformity – Part 1: General requirements 
/EN ISO/IEC 17050 -2 : 200 4 Conformity assessment – Supplier’s Declaration of C onformity – Part 2: Supporting 
documentation . 
10 The ‘number’ may be an alpha -numerical code  or could also refer to a software version .  
11 In addition, whether this is expressly envisaged or not by the Union harmonisation legislation,  manufacturers are free to 
add a number identifying the Declaration of Conformity itself in line with EN ISO/IEC 17050 -2. Medical Device       
Medical Device Coordination Group Document                          MDCG 2020 -2 rev.1  
 
4.  The identification of the product allowing traceability. This is any relevant information 
suppleme ntary to point 1 describing the product and allowing for its traceability . Where relevant 
for the identification of the product , it may  contain an image, but unless specified as a 
requirement in the Union harmonisation legislation this is left to the discr etion of the 
manufacturer.  
5.  All relevant Union harmonisation legislation complied with; the referenced standards or other 
technical specifications (such as national technical standards and specifications) in a precise,  
complete and clearly defined way;  this implies that the version and/or date of the relevant 
standard is specified.12  
6.  If applicable, t he name and identification number of the notified body ,13 when it has been 
involved in the conformity assessment procedure ,14 15 and the reference to the relevant 
certificate.  
7.  If applicable, a ll supplementary information that may be required (for example category) . 
8.  The date of issue of the declaration; signature and title or an equivalent marking of the 
authorised person16 17 
 This could be any date after the complet ion of the conformity assessment , but must be before 
26 May 202 1 if the manufacturer wants to make use of the transitional period in Article 
120(3) and (4)  of the MDR . 
Every Declaration of C onformity must be based on proper technical documentation according to 
Annex VII para graph  3 of the MDD.  The technical documentation and the D eclaration of Conformity 
should be subject to appropriate  measures of document and record control. The Declaration  of 
Conformity is to be kept by the manufacturer and shall be at the  disposal of the competent  authorities 
for a period ending at least five years after the last product  has been manufactured.  
Necessary amendm ents/updates to the t echnical documentation should be done in a transparent 
manner. Both t he changes and the dates of when the changes were  made should be recorded. On the 
basis of the Declaration of Conformity and the corresponding technical documentation, the 
manufacturer should be able to demonstrate that the Declaration of Conformity was lawfully18 issued 
before 26 May 202 1 and that, subsequently, there are no significant changes  in the design or intended 
                                                           
12 According to the MDD , referencing st andards or technical specifications complied with is voluntary .  
13 For class I devices in scope of this guidance document, the involvement of a notified body is not required.  
14 Not all Union harmonisation legislation requires the intervention of a notified  body (e.g. the Low Voltage Directive and the 
Toys D irective . 
15 The name and address of the person who keeps the technical documentation may also be required by some pieces of Union 
harmonisation legislation since according to those, not only the manufactu rer shall keep the technical documentation.  
16 This could be the m anaging director of the company or another representative of the company to whom this responsibility 
has been delegated.  
17 It is not necessary for the signatory to be domiciled in the Europea n Union. A manufacturer established outside the Union 
is entitled to carry out all the conformity assessment procedures at his premises and, to sign the Declaration of Conformity . 
18 Lawfully according to the Directive and to any relevant national provisions which apply.  Medical Device       
Medical Device Coordination Group Document                          MDCG 2020 -2 rev.1  
 
purpose19 in the meaning of Article 120(3) MDR. Taking into account Article 123(3) and 123 (3)(d), 
and a s EUDAMED will not be fully functional in May 202 1, it is required that the manufacturer keep 
the Declaration of Conformity together with the  technical documentation available to the Competent 
Authorities . This would also include details o f all device registrations and economic operator 
registrations completed pursuant to national provisions implementing the requirements of Articles 14 
(1) and (2) of Directive 93/42/EEC.  
 
 
                                                           
19 Guidance on significant changes under Article 120 of the MDR with regard to devices covered by certificates according to 
MDD or AIMDD .