A Two-Part Exploration into Understanding IVDR and Success Stories of Chinese IVD Companies Achieving IVDR CE Certification

CACLP's initiative to launch an English/Chinese webinar for non-EU IVD players in next January is set to provide a crucial platform for understanding EU IVDR registration requirements. 

As the webinar unfolds, a significant focus will be placed on shedding light on the intricacies of In Vitro Diagnostic Regulation (IVDR) and its implications for companies seeking certification.

Understanding IVDR

(Credit for the information provided below goes to TÜV SÜD.)

IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. 

It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC). 

As a European regulation, it is effective in all EU member states and EFTA states immediately without need to be transferred into the law of respective states, however national laws may be adapted to back up some requirements in more detail.

Under Regulation EU 2023/607, the ‘sell off’ dates in article 110(4) of the IVDR are removed. This allows in vitro diagnostic medical devices which are already placed on the market, to remain on the market without having to be disposed of. This can only be done if the devices were originally compliant to previous legal requirements under In Vitro Diagnostic Directive (IVDD).

The transition period depends on the class of the IVD device under the current Directive and Regulation 2017/746 as well as additional conditions available below in the next section:

·    Devices placed on the EU market prior to 26 May 2022 as self-declared (i.e. with no notified body involvement) and that require the involvement of a notified body under the Regulation, may be placed on the market or put into service under the Directive until the following dates:

    ·    26 May 2026, for class D devices;

    ·    26 May 2027, for class C devices;

    ·    26 May 2028, for class B devices and class A devices placed on the market in sterile condition.

·    Devices placed on the EU market prior to 26 May 2022 with notified body certificate, may be placed on the market or put into service under the Directive until 26 May 2025.

Part of the Chinese IVD Companies Successfully Attaining IVDR CE Certification

(The following information is sourced from publicly accessible sources.)

-    In December 2020, Snibe's MAGLUMI® TSH assay and MAGLUMI® CA 19-9 assay were certified the IVDR CE Certification by TÜV SÜD Product Service GmbH an EU Notified Body, making Snibe one of the first IVDR CE-certified manufacturers for CLIA products in Asia.

-    In January 2021, Mindray's β2-mG determination kit obtained the IVDR CE certificate issued by TÜV SÜD.

-    In August 2021, Wondfo’s HbA1c test kits (immunofluorescence assay) and C-reactive protein test kits (immunofluorescence assay) obtained IVDR CE certificates.

-    In October 2021, YHLO received its first IVDR Certificate from BSI, one of the most reputable notified bodies under IVDR. The certificate covers Anti-TPO—a Thyroid Peroxidase Antibody Assay Test Kit, PCT—A Procalcitonin Assay Test Kit and etc., which are applied to Chemiluminescence Immunoassay platform.

-    In March 2022, EasyDiagnosis’s 4 products: Disposable virus sampling tube, Sample release Reagent, Full-Automatic Nucleic acid Extraction and Purification Instrument and Nucleic Acid (DNA/RNA) Extraction Kit have passed EU IVDR registration.

-    In June 2022, Sansure Obtains CE Mark under IVDR Certification for New POCT iPonatic S-Q36A

-    In September 2022, Hotgen declared its wholly-owned subsidiary's product MQ60 smart passed the IVDR CE certification.

-    In April 2023, Gongdong Medical received the EU Quality Management System Certificate issued by TÜV SÜD. The company's vacuum blood collection series products formally passed the IVDR CE certification.

-    In August 2023, Zybio successfully obtained the EU Quality Management System Certificate (IVDR) issued by TüV SüD, covering our products in Clinical Chemistry, CLIA, Hematology, etc.