EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
[…](2021) XXX  draft  
 
COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down common specifications for certain class D in vitro diagnostic medical devices 
in accordance with Regulation (EU) 2017/746 of the European Parliament and of the 
Council   EN 1  EN COMMISSION IMPLEMENTING REGULATION (EU) …/...  
of XXX  
laying down common specifications for certain class D in vitro diagnostic medical devices 
in accordance with Regulation (EU) 2017/746 of the European Parliament and of the 
Council  
(Text with EEA relevance)  
THE EUROPEAN COMMISSION,  
Having regard to the Treaty on the Functioning of the European Union , 
Having regard to Regulation (EU) 2017/746  of the  European Parliament and of the Council  of 
5 April 2017 on in vitro  diagnostic medical devices and repealing Directive 98/79/EC and 
Commission Decision 2010/227/EU1, and in particular Article 9 (1) thereof,  
Whereas:  
(1) For certain class D in vitro  diagnostic medical devices  falling within the scope of 
Regulation (EU) 2017/746 , harmonised  standards do not exist  as regards certain 
requirements of Annex I to that Regulation, and there is a need to address public 
health concerns as  the risk associated  with the use of those devices is significant for  
public health  and patient safety . It is therefore appropriate to adopt  common 
specifications for those devices  in respect of those requirements.  
(2) Regulation (EU) 2017/746 replaces Directive 98/79/EC of the Eu ropean Parliament 
and of the Council2. The common technical specifications set out  in Commission 
Decision 2002/364/EC3 for certain  devices covered by Directive 98/79/EC remain 
relevant. Those common technical specifications have therefore been taken into 
account and where necessary updated to reflect  the state of the art.   
(3) To allow manufacturers, other economic operators, notified bodies and other actors  to 
adapt to this Regulation , and to ensure its proper application, it is appropriate to defer 
its appli cation . However, in the interest of public health and patient safety, 
manufacturers should be allowed to comply with the common specifications  laid down 
in this Regulation  on a voluntary basis before its date of application.  
(4) To ensure a continuous high level of safe ty and performance of devices, as a 
transitional measure it should be provided  that devices that are in conformity with 
Decision 2002/364/EC are to be presumed to be in conformity with the requirements 
for certain  performance characteristics set out in Annex I to Regulation (EU) 2017/746 
until the date of application of this Regulation.  
(5) The Medical Device Coordination Group has been consulted.  
                                                 
1 OJ L 117, 5.5.2017,  p. 176. 
2  Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro 
diagnostic medical devices (OJ L 331 , 7.12.1998, p. 1).  
3  Commission Decision of 7 May 2002 on common technical specifications for in vitro -diagnostic 
medical devices  (2002/364/EC) (OJ L 13 1, 16.5.2002, p. 17 ). 
 EN 2  EN (6) The measures provided for in this Regulation are in accordance with the opinion of the 
Committee  on Medical Devices ,  
HAS ADOPTED THIS  REGULATION:  
Article 1  
Common specifications  
This Regulation lays down common specifications for certain  class D  in vitro diagnos tic 
medical devices  in respect of the requirements regarding  the performance characteristics set 
out in Section 9.1, points (a) and (b), Section 9.3 and Section 9.4, point (a), of Annex I to 
Regulation (EU) 2017/746 .  
Annex I lays down common specifications for devices covered by Annexes II  to XI II, as 
specified in that  Annex . 
Annex I I lays down common specifications for devices intended for detection of  blood group 
antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems . 
Annex I II lays down common specifications for devices intended for detection or 
quantifica tion of markers of human immunodeficiency virus ( HIV) infection . 
Annex IV lays down common specifications for devices intended for detection or  
quantification of markers of human T -cell lymphotropic virus (HTLV) infection . 
Annex V lays down common specific ations for devices intended for detection  or 
quantification of markers of hepatitis C virus (HCV) infection . 
Annex V I lays down common specifications for devices intended for detection or 
quantification of markers of hepatitis B virus (HBV) infection . 
Annex VI I lays down common specifications for devices intended for detection or 
quantification of markers of hepatitis D virus (HDV)  infection . 
Annex VIII lays down common specifications for devices intended for detection  of markers of 
variant Creutzfeldt -Jakob disease  (vCJD) . 
Annex IX lays down common specifications for  devices intended for detection  or 
quantification of markers of cytomegalovirus  (CMV)  infection . 
Annex X lays down common specifications for  devices intended for detection or 
quantification of markers of Epstein -Barr virus  infection  (EBV) . 
Annex X I lays down common specifications for  devices intended for detection of markers of 
Treponema  pallidum  infection . 
Annex XI I lays down common specifications for  devices intended for detection  of markers of 
Trypanosoma cruzi  infection . 
Annex XI II lays down common specifications for devices intended for detection or 
quantification of markers of severe acute respiratory syndrome coronavirus 2 (SARS -CoV -2) 
infection .  
Article 2  
Definitions  
For the  purposes of this Regulation, the following definitions apply:  EN 3  EN (1) ʻtrue positive ʼ means a specimen known to be positive for the target marker and 
correctly classified by the device;  
(2) ʻfalse negative ʼ means a specimen known to be positive for the target marker and 
misclassified by the device;  
(3) ʻfalse positive ʼ means a specimen known to be negative for the target marker and 
misclassified by the device;  
(4) ʻthe limit of detection ʼ (ʻLOD ʼ) means the smallest amount of the target marker that 
can be detected;  
(5) ʻnucleic ac id amplification techniques ʼ (ʻNAT ʼ) means  methods of detection and/or 
quantification of nucleic acids by either amplification of a target sequence, by 
amplification of a signal or by hybridisation;  
(6) ʻrapid test ʼ means a qualitative or semi -quantitative in vitro  diagnostic medical 
device , used singly or in a small series, which involve s non-automated procedures 
(except the reading of results) and has  been designed to give a fast result;  
(7) ʻrobustness ʼ means the capacity of an analytical procedure to remain una ffected by 
small but deliberate variations in method parameters and provides an indication of its 
reliability during normal usage;  
(8) ʻcross -reactivity ʼ means the ability of non -target analytes or markers to cause false  
positive results in an assay because of  similarity, e.g. the ability of non -specific 
antibodies binding to a test antigen of an antibody assay, or the ability of non -target 
nucleic acids to be reactive in a NAT assay ; 
(9) ʻinterference ʼ means the ability of unrelated substances to affect the result s in an 
assay;  
(10) ʻwhole system failure rate ʼ means the frequency of failures when the entire process is 
performed as prescribed by the manufacturer;  
(11) ʻfirst-line assay ʼ means a device used to detect a marker or analyte, and which may 
be followed by a confirmatory assay ; devices intended solely to be used to monitor a 
previously determined marker or analyte are not considered first line assays;  
(12) ʻconfirmatory assay ʼ means a device used for the confirmation of a reactive result 
from a first line assay;  
(13) ʻsupplemental assay ʼ means a device that is used to provide further information for 
the interpretation of the test result of another assay;  
(14) ‘virus typing device’  means a devic e used for typing with already known positive 
samples, not used for primary diagnosis  of infection or for screening;  
(15) ʻ95% positive cut -off value ʼ means the analyte concentration where 95% of test runs 
give positive results following serial dilutions of an international reference material, 
where available, e.g. a World Health Organisation (WHO) International Standard or 
reference material calibrated against the WHO International Standard.  
 
Article 3 
Transitional provisions   
 EN 4  EN 1. From … [OP: please insert the dat e of entry into force of this Regulation ] until … 
[OP: please insert the date  – 2 years after the date of entry into force of this 
Regulation ], devices that are in conformity with the common technical specifications 
set out in Decision 2002/364/EC  shall be  presumed to be in conformity with the 
requirements regarding  the performance characteristics set out in Section 9.1, points 
(a) and (b), Section 9.3 and Section 9.4, point (a), of Annex I to Regulation (EU) 
2017/746 . 
During that period manufacturers of devices that are not in conformity with the 
common technical specifications set out in Decision 2002/364/EC  shall duly justify 
that they have adopted solutions that ensure a level of safety and performance t hat is at 
least equivalent thereto . 
2. From  … [OP: please insert the date of entry into force of this Regulation] until … 
[OP: please insert the date – 2 years after the date of entry into force of this 
Regulation ] devices that are in conformity with the common specifications laid down 
by this Regulati on shall be presumed to be in conformity with the requirements 
regarding the performance characteristics set out in Section 9.1, points (a) and (b), 
Section 9.3 and Section 9.4, point (a), of Annex I to Regulation (EU) 2017/746.  
 
Article  4 
Entry into force  and date of application  
This Regulatio n shall enter into force on the twentieth  day following that of its publication in 
the Official Journal of the European Union . 
It shall  apply from … [OP: please insert the date – 2 years after the date of entry into force  of 
this Regulation ]. 
However , Article 3 shall apply from  … [OP: please insert the date  of entry into force  of this 
Regulation ].  
 This Regulation shall be binding in its entirety and directly applicable in all Member States.  
Done at Brussels,  
 For the Commission  
 The President  
 Ursula von der Leyen