OGT blog

The new European Union IVD Regulation (EU) 2017/746 (IVDR) aims to improve upon the quality, safety, and reliability of in vitro diagnostic devices (IVDs). While the transition period for Class C devices (where a number of FISH probes sit) may seem far away, the inevitable transition has key implications for users of in vitro diagnostic medical devices Directive (98/79/EC) (IVDD) FISH probes: 

  • After this transition period, IVDD probes will not be available for use in diagnostic applications, and face the risk of being discontinued
  • Manufacturers will have to comply with more robust rules governing clinical evidence, product safety and performance, manufacturing systems and beyond

OGT started preparing for IVDR the moment legislation was first enacted in 2017, and our commitment to quality led to us becoming the first manufacturer of FISH probes to achieve IVDR status. But some manufacturers may be reluctant to invest the necessary time and resources, leaving many IVDD FISH probe users in a precarious position.

If you currently rely upon IVDD probes and are unsure about when or how to switch to a new IVDR platform, we’re here to help you. So why should you move to IVDR?

1. Stay ahead of the curve

With an established in-house IVDR pipeline, we have a range of IVDR-certified CytoCell® FISH probes for the diagnosis of haematological malignancies and prenatal conditions, with more continually being certified.

Manufacturers who move later are more likely to face delays getting their products IVDR certified due to limited Notified Body capacity with an increasing queue of products.

By making the switch to certified IVDR CytoCell FISH probes now, you can rest-easy, knowing that your diagnostic process will be compliant prior to the IVDR deadline.


2. It’s easier and cheaper than you think

We know adapting existing clinical diagnostic workflows can be a daunting prospect for many, but when you transition to IVDR FISH probes with OGT, we’ll help you minimise any disruption to your processes.

Many of our existing high quality IVDD FISH probes will transition to become IVDR-certified and are identical to the IVDR version in terms of formulation, design, specification and Intended Purpose.

Reassuringly, users of OGT IVDD CytoCell products face no additional validation work when making the switch to our IVDR range, and you won’t have to pay more with IVDR-certified probes that are price matched to their IVDD equivalents.

All CytoCell customers are guaranteed unlimited support from OGT’s expert Field Application Scientist team, who can guide you through the process including visiting your lab to give hands-on advice and help implement IVDR probes into your workflow.


3. Reap the benefits of robust regulation

FISH probes play a fundamental role in making the right diagnostic decisions for patients. Additionally, gaining an accurate molecular diagnosis is often the first step towards a patient’s treatment and recovery.

For labs, regulations help by promoting standardisation in the design, performance and data reporting of IVD devices. This makes it easier for labs to integrate IVDs into their workflows and yield consistent and reproducible results.

With the knowledge that each probe has undergone rigorous testing and validation to meet the stringent standards set out in the IVDR, you can be confident in the diagnostic results produced by our devices.

Future-proof your diagnostic workflows today

By choosing OGT, an industry-leading FISH probe manufacturer, you can choose from a growing library of IVDR-certified probes, and benefit from our unparalleled expertise and support.

Request an evaluation kit today

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