LC & LC-MS compliant with In Vitro Diagnostic Regulation (IVDR)

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Shimadzu offers Liquid Chromatography and Mass Spectrometry medical devices.

How Shimadzu is simplifying your compliance workload for the new IVD regulation!

What is the New EU In Vitro Diagnostic Regulation (IVDR)?

Figure 1. IVDR risk-based classification

Figure 1. IVDR risk-based classification

New In Vitro Diagnostic Medical Device Regulation (IVDR) (EU) 2017/746 was published in EU Official Journal in May 2017 in order to ensure a high level of safety and health whilst supporting innovation. It applies from 26 May 2022 and replaced the previous IVD Directive (98/79/EC). This regulation set rules for in vitro diagnostic devices such as reagent, calibrator, kit, instrument, and software intended by the manufacturer to be used for diagnostic purposes. IVDR retains some concepts of IVD Directive such as CE marking or essential requirements (under IVDR called “general safety and performance
requirements”). As in the past, the manufacturers have to demonstrate that they and their devices meet the requirements through conformity assessment procedure. Different from IVD Directive, however, IVDR introduced the riskbased classification (Figure 1). Under IVDR devices are classified in four: The devices with highest risks are classified in class D. The class A devices have low risks and include products for general laboratory use, accessories which possess no critical characteristics.

 

Figure 2. IVDR Transition Timeline

Figure 2. IVDR Transition Timeline

As shown Figure 2, self-declaration of conformity by the manufacturer which meet the requirements of IVDR is necessary to place the class A devices* on the EU market from 26 May 2022. Class B**, C, and D devices need the certification from the accredited Notified Body (NB) to be placed on the EU market. While only 8 % of devices required NB certification under the IVD Directive, 78 % of devices require NB certification under IVDR.1 Despite the fact, the number of NBs accredited in the EU is small.2 For that reason, in December 2021, the transition period has been postponed depending on the class (class B** until 26 May 2027, class C until 26 May 2026, and class D until 26 May 2025). The European Commission presented a further postponement proposal in January 2024.3 If this amendment proposal is published in the official Journal as it is, the transition period of class B** devices will be postponed until 31 December 2029, class C until 31 December 2028 and class D until 31 December 2027.

 

In-house devices and IVDR
Another big difference between IVDR and IVD Directive is that IVDR regulates so called “in-house devices” what you know as LDTs or lab-developed tests. IVD medical devices can be manufactured and used within EU health institutions (in-house devices), on a non-industrial scale, to address the specific needs of target patient groups which cannot be met, or cannot be met at the appropriate level of performance, by an equivalent CE-marked device available on the market. In-house devices are exempted from most of the provisions of IVDR, if the health institution  fulfills the conditions laid out in IVDR Article 5(5). Here, “health institutions” include not only hospitals but also laboratories and public health institutes which support the health care system and/or address patient needs, but do not treat or care for patients directly.4 For the details, MDCG guidance5 is available. 
Currently – as transition period – in-house device is possible for health institutions without justifying in their documentation that the target patient group’s specific needs cannot be met, or cannot be met at the appropriate level of performance, by an equivalent device available on the market. However, from 26 May 2028 a justifying documentation will be necessary. Also here the European Commission presented a further postponement proposal. If this proposal is published as it is, this will be postponed to 31 December 2030.6
“Old” device
It is possible to continue using IVD Directive products already on the market. IVD devices that were placed on the market prior to 26 May 2022 in accordance with IVD Directive and are still on the market or in use after 26 May 2022 are called “old” devices. These “old” devices are in principle not the subject to IVDR requirements. So, these “old” devices can be further used in your laboratory. However, IVDR provisions which do not directly impact the device, its documentation or the conditions for the placing or making devices available on the market apply also for these “old” devices. Concretely, right and obligations of competent authorities with regard to market surveillance activities (IVDR Article 88 to 95) apply also to “old” devices after 26 May 2022. Also, the reporting and analysis of serious incidents and field safety corrective actions occurring after 26 May 2022 should be also done in accordance with IVDR Article 82 and 84, except for reporting of incidents and market surveillance activities.7

Shimadzu's CL Series

If a Research Use Only (RUO) HPLC or LC-MS/MS is used for diagnostic purposes, it may be converted to in-house device in accordance with Article 5(5) of IVDR. However, the work required to meet the requirements of Article 5(5) is enormous. Therefore, we recommend the introduction of IVDR class A products for HPLC and LC-MS/MS to reduce the workload. Shimadzu has already launched IVDR Class A devices for HPLC (LC-40 CL) and LC-MS/MS (LCMS-8045/8050/8060/8060NX CL) in 2022. HPLC IVDR class A is available without MS. Each unit (pump, autosampler, oven, valve, and detector (UV)) is IVDR Class A, so the combination can be customized. For LC-MS/MS, series can be selected according to required sensitivity.

Shimadzu also launched an IVDR Class A device, the CLAM-2040 CL, a fully automated sample preparation module for Shimadzu LC-MS/MS that enables a seamless workflow from laborious pre-treatment to fully automated LC-MS/MS. The CLAM-2040 CL is not only seamless, but also flexible. Depending on the application, you can choose an IVDR class A compliant LC-MS/MS to be combined with the CLAM-2040 CL. The design also allows connection to LIS (Laboratory Information System) and LAS (Laboratory Automation System), enabling a wide range of tests and workflow improvements using LC-MS/MS. This IVD devices, in combination with commercially available IVD kit, is expected to relieve the user from the enormous amount of work necessary to meet the requirements of Article 5(5) of IVDR. Only the validation by combination is still required.

 

 

CL Series Liquid Chromatograph and Mass Spectrometry Listed Devices (for EU CE-IVD):

    Main Module P/N
LC Communications CBM-40 CL 228-45012-55
Nexera CL Liquid Chromatograph LC-40D X3 CL 228-65076-55
LC-40D XR CL 228-65000-55
LC-40B X3 CL 228-65078-55
Degassing Unit DGU-405 CL 228-65019-55
Nexera CL Autosampler SIL-40C X3 CL 228-65120-55
SIL-40C XR CL 228-65103-55
Nexera CL Column Oven CTO-40C CL 228-65202-55
Valve Unit FCV-S CL 228-65600-55
Nexera CL UV Detector SPD-40 CL 228-65312-55
LCMS Triple Quad LC-MS/MS LCMS-8045 CL 225-31400-55
225-31800-55
LCMS-8050 CL 225-19600-55
225-19610-55
LCMS-8060 CL 225-27800-55
225-27810-55
LCMS-8060NX CL 225-41600-55
225-41690-55
Automation CLAM automation module CLAM-2040 CL 241-18700-55
Software Software LC&LCMS LabSolutions CL Ver. 1.40 (DVD) 225-45811-55
Software LCMS LabSolutions Insight CL Ver. 1.1 (DVD) 225-45812-55
LabSolutions CL/LabSolutions Insight CL license ASSY 225-45813-55
Software LC LabSolutions CL Single LC (License) 223-63386-55
LabSolutions CL Add LC (License) 223-63387-55

NB: These instruments are only available in the target market where the conformity assessment procedure of the product (CE IVDR) is accepted.
These instruments are designed/developed, manufactured, installed and repaired under a certified Quality Management System according EN ISO 13485:2016 for medical devices and related services.

References

 

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