Huawin Testing Certification (Shenzhen) Co., Ltd.
+86 0755-28266382
info@huawinlab.com
7F,Building A, Shenye U Center, No.743, Zhoushi Road, Bao'an District, Shenzhen, China
Huawin Testing Certification (Dongguang) Co., Ltd.
+86 0769-85880813
info@huawinlab.com
3F, Building Jinghe, No.68, Huizhangdong Road, Houjie, Dongguang, China
The
In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation
applicable to in vitro diagnostic (IVD) medical devices. Entering into force on
the 25 May 2017 marking the start of a five-year transition period for
manufacturers and economic operators, the IVDR replaces the EU In Vitro
Diagnostics Directive (IVDD) 98/79/EC.
Harmonised standard
|
EN 375 |
Information supplied by the manufacturer with in vitro
diagnostic reagents for professional use |
|
EN 376 |
Information supplied by the manufacturer with in vitro
diagnostic reagents for self-testing |
|
EN 591 |
Instructions for use in vitro diagnostic instruments
for professional use |
|
EN 592 |
Instructions for use for in vitro diagnostic
instruments for self-testing |
|
EN 928 |
In vitro diagnostic systems – Guidance on the
application of EN 29001 and EN 46001 and of EN 29002 and EN 46002 for
in vitro diagnostic medical devices |
|
EN 980 |
Graphical symbols for use in the labelling of medical
devices |
|
EN 1658 |
Requirements for marking of in vitro diagnostic
instruments |
|
EN 12286 |
In vitro diagnostic medical devices – Measurement of
quantities in samples of biological origin – Presentation of reference
measurement procedures |
|
EN 12287 |
In vitro diagnostic medical devices – Measurement of
quantities in samples of biological origin – Description of reference
materials |
|
EN 12322 |
In vitro diagnostic medical devices – Culture media for
microbiology – Performance criteria for culture media |
|
EN 13532 |
General requirements for in vitro diagnostic medical
devices for self-testing |
|
EN 13640 |
Stability testing of in vitro diagnostic medical
devices |
|
EN 13641 |
Elimination or reduction of risk of infection related
to in vitro diagnostic reagents |
|
EN 13975 |
Sampling procedures used for acceptance testing of in
vitro diagnostic medical devices - Statistical aspects |
|
EN ISO 14971 |
Medical devices – Application of risk management to
medical devices |
|
EN ISO 18153 |
In vitro diagnostic medical devices - Measurement of
quantities in biological samples - Metrological traceability of values
for catalytic concentration of enzymes assigned to calibrators and
control materials |
|
EN 61010-2-101 |
Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 2101: Particular
requirements for in vitro diagnostic (IVD) medical equipment Reference
document: IEC 61010-2-101 |
|
EN ISO 18153 |
In vitro diagnostic medical devices - Measurement of
quantities in biological samples – Metrological traceability of values
for catalytic concentration of enzymes assigned to calibrators and control materials |
|
EN 61010-2-101 |
Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 2- 101: Particular
requirements for in vitro diagnostic(IVD) medical equipment |
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