At OGT, we committed early to the In Vitro Diagnostic Regulation (IVDR)! Since initiating discussions with a Notified Body in 2019, we have been working tirelessly to be 100% IVDR-ready and to meet conformity requirements in a timely and compliant manner.
We are delighted that the culmination of this hard work has led to the submission of our first tranche of CytoCell® fluorescence in situ hybridisation (FISH) probes important for patient management of haematological cancers and pre-natal conditions. This important milestone demonstrates our continued commitment to provide safe, reliable and effective products for you and your patients.
Further submissions will follow as we continue to pursue certification for our CytoCell FISH probes.
Be the first to know when our IVDR-certified FISH probes are available – sign-up now!Watch our video to help you get ready for IVDR
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 26th 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 26th 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.
All CytoCell IVD FISH probes are affected by the IVDR and need to be compliant by May 2026. Research Use Only (RUO) probes are not affected by the IVDR.
Our first submission of haematology and pre-natal FISH probes are awaiting IVDR certification. Once approved, the final stages of commercialisation of these probes will commence.
Be the first to know when our IVDR-certified FISH probes are available – sign up now!
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.
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.