Specialist support to meet IVD regulations

Close to 80% of healthcare decisions rely on information provided by in vitro diagnostics (IVDs). The results of these diagnostic tests significantly influence the way patients are diagnosed, but also their management, treatment and overall clinical outcomes.

The need to explore and adopt innovative, accurate and accessible diagnostics is essential to providing high quality, tailored and safe care.

New regulations for IVDs aim to enhance the safety, performance, and reliability of this type of diagnostics, ensuring that patients have access to high-quality diagnostic tools. For both users and manufacturers, the new regulatory requirements called ‘In Vitro Diagnostic Medical Devices Regulation’ (IVDR) have brought about significant changes to the diagnostic landscape presenting both challenges and opportunities.

They introduce a more rigorous risk-based classification system for IVDs, placing greater responsibility on those building tests to demonstrate the safety and performance of their products. This includes conducting comprehensive clinical studies and maintaining thorough post-market surveillance.

Here at the North East Innovation Lab our team can help evaluate and bring innovative products to market or wider use, to benefit more patients and colleagues. We are able to help our clients to meet the requirements of IVDR with the following specialist services:

• Clinical study design and execution: we have expertise in designing and executing clinical studies that meet IVDR requirements, ensuring that the data generated is robust and relevant.
• A biobank of over three million blood, soft tissue and biological clinical samples both archived and available prospectively with quick turnaround times.
• A range of specialist cellular pathology services including immunohistochemistry, multispectral imaging, tissue microarray.
• Risk assessment and management: we can assist manufacturers in conducting thorough risk assessments of their IVDs, identifying potential hazards and developing effective mitigation strategies.
• Evidence of performance, both analytical and clinical, in real world settings, including usability studies.
• Supporting post-market surveillance data activities as well as expanding scope.

Since 2002 in vitro diagnostic tests have been regulated in the UK as medical devices. In 2017 the EU introduced IVDR, which represented a significant overhaul of medical device regulations. 

Since leaving the EU the UK has entered into a transitional period of regulation, which mirrors IVDR for new devices but allows devices brought to market before 2022 to remain compliant with the older system. Whilst the UK is still in transition, we are likely to continue use large parts of the IVDR under our own framework. The transition through to the requirements presents challenges for test developers who are keeping their products on the market and those bringing out new devices – both which need to meet the new industry rules. 

The EU recently granted an extension to the transition for existing products to meet IVDR by a further two years. This will give manufacturers more time to make sure their existing products comply, and it should assure the users in the laboratory that the products won’t be withdrawn. 

Clinical evidence and performance evaluation

The concept for IVDs is fundamentally different from pharmaceuticals or therapeutic medical devices, as in vitro diagnostic tests provide accurate medical information about patients, assessed against medical information from other diagnostic options and technologies.

Under the regulations, the clinical benefit measures the positive impact of a device on screening, monitoring, or diagnosis for patients, patient management or public health. It is necessary to qualify the claims of the test more closely under the new requirements, often needing to link back the clinical aspects or conduct studies in representative patient groups.

Our laboratory teams are well paced to work closely with our hospital colleagues to carry out studies with representative groups and samples from our biobank which are archived or can be obtained prospectively. The clinical evidence of an IVD should demonstrate that the clinical benefit is achieved and that it meets safety and performance requirements, whilst supporting the intended purpose and performance of the device, as stated by the manufacturer. 

Performance evaluation is expected to take a ‘life cycle’ approach with a continuous process to generate and maintain the clinical evidence support a device’s intended purpose. Scientific developments and improvements to make devices state-of-the-art should be reviewed and assessed by the manufacturer on a regular basis as part of their continuous and pro-active post market surveillance activities

Stronger post market surveillance requirements mean developers will be collecting more data about performance of tests after they are released which gives labs more information about existing and new products. IVDR increases traceability and labelling requirements potentially making it easier for labs to isolate and identify defective tests.

By partnering with the Innovation Lab’s team of NHS scientists who work closely with Newcastle Hospitals’ clinicians, IVD test developers can gain access to the expertise and resources they need to navigate the complexities of the IVDR and bring their products to market confidently. We’re also interested in partnering with laboratories and hospital teams to increase the pipeline of samples to keep our biobank well stocked with clinical samples for research and testing the tests.

By working together we hope to harness the potential for innovation, ultimately improving patient care and enhancing public health.

Dr John Tyson
[email protected]