Be on track with IVDR

The most relevant information for clinical labs

Introduction

Why should clinical labs care?

The IVDR is the European Union’s renewed regulation including pre- and post-market requirements for IVD devices which came into force in May 2017 and was initially proposed to completely apply on May 26, 2022.

Under the IVDR, all currently CE marked in vitro diagnostic devices will have to be recertified according to the new requirements. Manufacturers of either new or already CE marked and available IVDs on the market will have to demonstrate compliance with the new IVDR requirements. To do so, the IVDR requires that manufacturers take specific actions, for example, conduct clinical studies and demonstrate that the safety and performance of the device is consistent with the device's risk class or risk rules.

The new IVDR classification system specifies the risk classes A through D, with A indicating low-risk products and D representing products with the highest risk to patients and the public.

The risk-based classification system introduced by the IVDR requires the involvement of a notified body in the approval of all IVDs (except class A non-sterile). The Notified Body works closely with the manufacturer and is responsible for the evaluation of the technical documentation of IVDs.

New IVDR transition period

The European Commission has published Regulation EU 2022/112, amending IVDR and extending the transition period for the rollout of the IVDR. Besides that, certain requirements of IVDR, such as Market Surveillance, Post Marketing Surveillance, Vigilance, Registration of Economic Operators, and Registration of Devices, apply from 26 May 2022 for all in vitro diagnostic devices, including those marked CE IVD under the former IVD directive.

IVDR Guide for Clinical Diagnostic Laboratories

IVDR places a significant burden on both IVD manufacturers and clinical diagnostic laboratories. Watch this informative webinar, in which Dr. Claudia Solimeo Meneghisse discusses IVDR product classification and timelines, and shares unique insights into the processes behind the IVDR certification and IVDR product readiness. She also elaborates on how to easily identify IVDR ready products and provides valuable information to clinical laboratories on securing a continuous supply of IVD products for diagnostic use.

Making sense of IVDR for LC-MS

Watch the webinar to learn more about the regulation and how it affects clinical laboratories using their own in-house testing (Laboratory Developed Tests).

This webinar answers the following questions:

  • What is IVDR and what are the timelines?
  • What are the requirements for in-house tests (LDTs)?
  • What are the next steps for your lab?

Download our whitepaper ‘Making sense of IVDR for LC-MS’ to learn more about IVDR for mass spectrometry LDTs.

We have outlined all the deadlines and highlighted all the relevant parts of IVDR into one digestible document.

Already CE marked under IVDR:

Request an offer for IVDR ready products here
  • MetCombi Plasma RIA (RE29111)
  • Testosterone Saliva Luminescence immunoassay (30191568, 30191569)
  • DHEA Saliva ELISA (RE52651)
  • Hydroflex Plus (30190374)
  • Infinite F50 Plus (30183570)
  • Magellan
    (30143623, 30143624, 30143625, 30143626, 30143627, 30143628)
  • SaliCap Set (RE69981 and RE69985)
  • dsDNA-Ab RIA (RE19011)
  • Testosterone Saliva ELISA (RE52631)
  • 17beta-Estradiol Saliva ELISA (30121045)
  • MuSK-Ab ELISA (RE51021)
  • Cortisol Saliva Luminescence Immunoassay (30221150, 30221151)
  • Cortisol Saliva ELISA (RE52611)
  • Melatonin direct Saliva ELISA (RE54041)
  • Free Testosterone ELISA (DB52181)
  • Normetanephrine ELISA (RE59171)
  • Cortisol ELISA (RE52061)
  • Estriol High Sensitive Saliva ELISA (30121046)
  • 17-OH Progesterone ELISA (RE52071)
  • 25-OH-Vitamin D ELISA (RE53041)
  • Melatonin sulfate Urine ELISA (RE54031)
  • 17beta-Estradiol Saliva Luminescence Immunoassay (RE62141, RE62149)
  • DHEA ELISA (RE52221)
  • Progesterone Saliva ELISA (RE52281)
  • Acetylcholine Receptor Autoantibodies (ARAb) RRA (30221148, 30221149)
  • sInterleukin-2-Receptor ELISA (30201813)
  • Histamine ELISA (RE59221)

IVDR certified products*:

See the certificate here
  • TriCat TM Urine ELISA (30143814)
  • CatCombi Urine ELISA (30146128)
  • Serotonin Urine ELISA (30192571)
  • Noradrenaline Urine ELISA (30146130)
  • Dopamine Urine ELISA (30146131)
  • Adrenaline Urine ELISA (30146129)
  • Metanephrine ELISA (RE59181)
  • Neopterin ELISA (RE59321)
  • Noradrenaline Urine ELISA (30146130)
  • TriCat TM Urine ELISA (30143814)
  • CatCombi Urine ELISA (30146128)
  • Dopamine Urine ELISA (30146131)
  • Serotonin Urine ELISA (30192571)
  • Adrenaline Urine ELISA (30146129)
  • Metanephrine ELISA (RE59181)
  • Neopterin ELISA (RE59321)

If the main responsibilities within IVDR are on the shoulders of the manufacturers, why should clinical labs care?

Here are the 5 main things you need to know:

  • Know when you need to act: Even though, it is not immediately necessary to shift from “IVDD” to “IVDR” devices, Laboratories should keep an eye on the end of transition periods for the different device Classes.
  • Start early: Laboratories need to consider that devices that are not yet certified under the IVDR will need to undergo Notified Body assessment in the near future. Notified Body assessments are lengthy and complex processes.
  • Stay informed: For those devices that are not certified under IVDR yet, the Laboratory can request the transition plans from the manufacturers.
  • Be on track with IVDD product changes: IVDD Products can be produced and sold after 26 May 2022, however no significant change in design or intended purpose is possible. If the product is changed it can only be sold with an IVDR certificate. The manufacturers now have to take a longer “time-to-market” into consideration for modified or new products.
  • Don’t panic: In general, when the laboratory switches from IVDD devices to IVDR , there are no additional user requirements. If the device is the same (only changed certification), there is no need for a new validation.

Tecan has embraced the challenge to deliver reliable, accurate and safe immunoassays for clinical diagnostics according to your needs. The current Tecan portfolio has been reviewed in order to ensure compliance and seamless product offering to the clinical laboratories. All our CE-IVDD products have been classified according to IVDR, to allow for sales during the accepted transition period.

Would you like to get a dedicated offer for IVDR products or receive more information?
Just fill in the form and we will contact you with the answers to your questions.

 

* Product availability and regulatory status may vary across regions outside the EU depending on local country-specific registration. CE IVD under IVDR to be launched soon. Consult with your Tecan associate for further information.