Regulation (EU) 2017/746 (IVDR) is a new regulatory framework for in vitro diagnostic (IVD) medical devices, which was introduced in 2017 to replace Directive 98/79/EC (IVDD). Following a 5-year transition period, IVDR became effective across the European Union (EU), European Economic Area (EEA) and Turkey on 26^th May 2022. IVDR also applies to Northern Ireland because of the Northern Ireland Protocol to the Brexit withdrawal agreement.

The new Regulation brings revolutionary changes to the IVD industry. It sets higher standards for quality and safety for in vitro diagnostic medical devices (including in-house devices) to ensure the highest level of public health protection. By creating a more robust, transparent and sustainable regulatory framework, the IVDR will also ensure fairer market access for all diagnostic manufacturers.

Objectives of IVDR

The most significant change is the new risk-based classification system and the requirement that manufacturers of IVD devices must consult a Notified Body for approval (Class A non-sterile exempted). Under the new Regulation, self-declaration is no longer permissible for higher risk devices (Classes B-D, plus sterile Class A).

Successful transition to IVDR-certification requires manufacturers to prepare more stringent technical documentation related to scientific validity, analytical performance, clinical performance and risk management, in addition to conducting comprehensive post-market surveillance. To improve transparency and traceability, unique device identification (UDI) is required for every device, and these must be registered in EUDAMED, the new European database on medical devices.

The IVDR date of application was 26^th May 2022.

From this date, any new (or significantly modified) IVD device placed on the market must comply with the IVDR.

For existing products already on the market, the EU recently granted an extension to the transition period, with the length of extension being dependent upon the risk class. CytoCell IVD FISH probes are categorised as Class C devices and as such need to be fully compliant by May 2026.

The IVDR will affect every FISH probe on the market as they must comply with the new Regulation by May 2026 or become RUO products.

Available now!

Sixteen (16) CytoCell FISH probes that play a critical role in the management of patients with haematological cancers and prenatal conditions have been IVDR-certified and are available to order:

Haematological malignancies

• AML1 (RUNX1) Breakapart FISH Probe
• AML1/ETO (RUNX1/RUNX1T1) Translocation, Dual Fusion FISH Probe
• BCR/ABL (ABL1) Translocation, Dual Fusion FISH Probe
• BCR/ABL (ABL1) Plus Translocation, Dual Fusion FISH Probe
• CBFB Breakapart FISH Probe
• CBFβ (CBFB)/MYH11 Translocation, Dual Fusion FISH Probe
• CKS1B/CDKN2C (P18) Amplification/ Deletion FISH Probe
• Del(5q) Deletion FISH Probe
• Del(7q) Deletion FISH Probe
• Del(20q) Deletion FISH Probe
• EVI1 (MECOM) Breakapart FISH Probe
• FAST PML/RARα (RARA) Translocation, Dual Fusion FISH Probe
• IGH/MAF Plus v2 Translocation, Dual Fusion FISH Probe
• MLL (KMT2A) Breakapart FISH Probe
• P53 (TP53)/ATM Combination Deletion FISH Probe

Prenatal testing

• Prenatal 13 and 21 Enumeration FISH Probe Kit

Evaluation kits

Uncertain whether your current FISH probe(s) will become IVDR-certified? Switch to a CytoCell IVDR FISH probe and be reassured that your chosen probe is already fully compliant. We can help you start the transition early by validating our IVDR-certified FISH probes - request your complimentary evaluation kit today!

Request an evaluation kit

Existing CytoCell customers

Current users of CytoCell IVDD FISH probes can be assured that our IVDR equivalent probe designs remain unchanged, so there is no requirement to re-validate your probes.

Further certifications

Additional IVDR-certified probes will follow over the coming months as we continue to pursue certifications for our CytoCell FISH probes. Be the first to know when new IVDR probes become available – sign-up today.

Revalidation

Hospital and commercial diagnostic testing labs that use CE-IVDR FISH probes according to the manufacturer’s published method, and for the Intended Purpose, are classified as “users”. There are no additional requirements for users provided that the laboratory does not change the Intended Purpose or method.

Many of OGT’s existing CE-IVDD FISH probes will transition to become IVDR-certified.  The majority of the IVDR FISH probes will be identical to the IVDD version in terms of formulation, design, specification and Intended Purpose, so there is no requirement for additional validation work to be performed.

Health Institution Exemption for “In-House Devices”

IVDR also introduces a common set of rules for in-house devices that are manufactured and used within the same Health Institution. Although the use of in-house devices is largely prohibited under IVDR, there are exceptions provided that in-house devices meet certain safety and performance requirements.

Key requirements:

• In-house devices are permissible only if there is no “equivalent device” available on the market that meets the needs of the target patient group (unless its performance is deemed insufficient)
• Health Institutions must adhere to IVDR Article 5(5)
• In-house devices must meet the General Safety and Performance Requirements (GSPRs) of IVDR Annex I
• EU Member States will oversee in-house devices manufactured and used within the healthcare institutions in their territory

Find out more about these exemptions on the European Union website

EUDAMED

With the implementation of the IVDR, a new European Database on Medical Devices (EUDAMED) has been launched that will provide an overview of all commercially available devices CE marked under IVDR, including the specifications of the assay, limitations, performance and UDI information. This will enable laboratories to make a more informed decision on which device is best suited for their needs. Additionally, devices with Notified Body certification for IVDR will include the four-digit Notified Body identification number on the label for greater confidence and traceability.