INHALT

Commission Implementing Regulation (EU) 2022/1107 of 4 July 2022 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)

COMMISSION IMPLEMENTING REGULATION (EU) 2022/1107
of 4 July 2022
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)
Article 1
Common specifications
Article 2
Definitions
Article 3
Transitional provisions
Article 4
Entry into force and date of application
ANNEX I
GENERAL COMMON SPECIFICATIONS
Part I – Requirements for performance characteristics of devices covered by Annexes II to XIII
Part II – Requirements for performance characteristics of devices referred to in Annexes III to XIII
ANNEX II
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OF BLOOD GROUP ANTIGENS IN THE ABO, RH, KELL, DUFFY AND KIDD BLOOD GROUP SYSTEMS
Scope
Table 2. Manufacturer’s batch-to-batch consistency testing of reagents and reagent products to determine blood group antigens in the ABO, Rh, Kell, Duffy and Kidd blood group systems
1.
Test reagents
2.
Control materials (red cells)
ANNEX III
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION
Scope
Definitions
Table 5. Qualitative and quantitative NAT devices for HIV RNA
ANNEX IV
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF HUMAN T-CELL LYMPHOTROPIC VIRUS (HTLV) INFECTION
Scope
Table 4. NAT devices for HTLV I/II
ANNEX V
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF HEPATITIS C VIRUS (HCV) INFECTION
Scope
Table 5. Qualitative and quantitative NAT devices for HCV RNA
ANNEX VI
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF HEPATITIS B VIRUS (HBV) INFECTION
Scope
Table 5. Qualitative and quantitative NAT devices for HBV DNA
ANNEX VII
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF HEPATITIS D VIRUS (HDV) INFECTION
Scope
Table 2. Qualitative and quantitative NAT devices for HDV RNA
ANNEX VIII
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OF MARKERS OF VARIANT CREUTZFELDT-JACOB (vCJD) DISEASE
Scope
ANNEX IX
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF CYTOMEGALOVIRUS (CMV) INFECTION
Scope
Table 2. Qualitative and quantitative NAT devices for CMV DNA
ANNEX X
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF EPSTEIN-BARR VIRUS (EBV) INFECTION
Scope
Table 2. Qualitative and quantitative NAT devices for EBV DNA
ANNEX XI
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OF MARKERS OF
TREPONEMA PALLIDUM
INFECTION
Scope
ANNEX XII
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF
TRYPANOSOMA CRUZI
INFECTION
Scope
Table 3: NAT devices for T. cruzi DNA
ANNEX XIII
COMMON SPECIFICATIONS FOR DEVICES INTENDED FOR DETECTION OR QUANTIFICATION OF MARKERS OF SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS 2 INFECTION
Scope