In Vitro Diagnostics (IVDs) are tests used on biological samples (for example, blood, urine, saliva or tissues) to determine the status of a person’s health.

These tests can be used to prevent poor health and diagnose illness earlier.

When used within a patient’s care pathway, these tests can inform treatment options, save and improve lives, support clinical staff and create a more effective and efficient healthcare system.

An in vitro diagnostic (IVD) test is predominantly to give doctors and healthcare professional more information to inform clinical decisions. Most tests will not lead to a diagnosis on their own but will make up the clinical picture. They are a key part of the UK’s preparation for future pandemics.

Tests are also used for monitoring treatment and existing conditions such as diabetes, deciding which drugs to use, and screening for disease in at-risk sectors of the population. They are also important for ruling out causes of disease.

IVDs are heavily used to test donated blood for infection.

IVDs are widely used in hospitals in all the specialities of the pathology department and also on wards, in A&E, ICU and operating theatres, as well as in primary care settings such as GPs.

Most people are aware of pregnancy tests available in high-street pharmacists, and many are aware of the blood glucose monitors used by people with diabetes to help manage their therapy.

The IVD Industry continues to develop many more tests in designs specifically for home use, such as those used to monitor coagulation therapy, or to screen for various forms of cancer. Products to help pinpoint a woman's most fertile stage in her menstrual cycle, to screen for the biochemical markers associated with osteoporosis, and simple tests for urinary tract infection are amongst those arriving on the pharmacists' shelves. During the COVID-19 pandemic, manufacturers built many self-testing IVDs that are now commercially available, and BIVDA worked with the UK Government to ensure these tests were accurate and available.

Although all self-testing products have extensive information in the packaging explaining their use, the pharmacist will also be willing to discuss any questions about them that the consumer might have. BIVDA advises anyone with concerns about their health to speak to their GP and self-test results can be useful to aid this discussion.

Anyone who has visited a medical laboratory will know that it is a "high tech" world, with automated machines testing hundreds of samples a day. Many hundreds of sample components can be measured, but usually between two and ten are measured for each sample. Some tests (for example biological cultures) take time, but most results are available within minutes or even faster in an emergency situation.

The results are sent to the doctor in the form of a laboratory report for each sample that gives the results in comparison with normal values. In many cases the doctor will discuss the results with and/or request additional information from specialists in the medical laboratory.

Moving diagnostic tests to the point of care (POC) has the potential to alter substantially the delivery of care to patients, allowing rapid diagnosis of patients at the bedside, in general practice, or in the community. Where a patient is seriously ill, requires triage, or may need to be isolated, POC testing can save lives.

Patient’s electronic medical records can be updated in real time, allowing immediate detection of any changes of condition, tailored medication doses based on their effect, and making of clinical decisions based on real time data.

Some point of care tests are mobile, meaning they can be conducted anywhere – at home, at the scene of an incident, or deployed to support a major incident.

Numerous randomised clinical trials using point of care testing demonstrate improved patient outcomes compared to conventional laboratory testing.

You can read more about the benefits of POC testing in our case study New Models of Care (page 8).

Genetic (or genomic) testing looks at a person’s genes to find changes which may cause health issues. This is a rapidly developing area of testing in which the UK is world-leading.

Technologies now available allow a more reliable estimation of the risks of disease that individuals have because of their genetic make-up, or testing the genetic material of micro-organisms causing infection in order to be able to identify and treat them more precisely.

Information on an individual’s genome is increasingly valuable to establish their reaction to different commonly used drugs, predict health issues and allow identification of rare and inherited disease. It can allow a patient to make lifestyle changes for reduce the risk of future health issues, or to make informed decisions as to whether an inherited health condition may affect relatives and children.

Companion diagnostic is a term used for a test which is required for the safe and effective use of a therapeutic, such as a drug or medicine. These identify if patients are likely to benefit from a course of therapy, to indicate how well a treatment is working, or to identify which patients are at risk of side effects.

Companion diagnostics are heavily used in the care of cancer patients to assess whether their personal tumour is capable of being treated by that therapy.

A similar term is complementary diagnostic, which means the test is useful – but not essential – before using a therapeutic.

The importance of in vitro diagnostics (IVDs) in tackling the antimicrobial resistance (AMR) challenge cannot be overstated. AMR is where the microorganisms which cause disease (including bacteria, viruses, fungi and parasites) evolve and can no longer be treated by antimicrobial medicines, such as antibiotics.

The widespread use of broad-spectrum antibiotics has helped to create multi-drug resistant strains of bacteria. No new class of antibiotics has been developed since the 1980s, and there are few alternatives on the horizon. This is of significant concern to the NHS and UK Government.

The greater adoption of IVDs would lead to a reduction in cases of unnecessary antibiotic prescribing by:

1. Reducing time to appropriate treatment decision.
2. Allowing for a more targeted use of therapy against infection.

Urgent action is required to halt AMR and BIVDA strongly urge healthcare professionals in the UK to make use of the quick, accurate and effective IVDs already available to them. Until IVDs are more widely adopted, we will not be able to combat AMR effectively.

An in-house test is a test which:

• Has been designed and developed in a public health or NHS laboratory and with reagents produced in the laboratory
• Is used off-label- i.e. a commercial test which is CE marked but where the user does not comply with the manufacturer’s instructions for use in some significant way
• Used for a clinical purpose for which it has not been designated by the manufacturer
• Is not CE-marked but is sold for Research Use Only where the results are used to support clinical decisions or disease management

To learn more about in-house testing, please read our report: Safe and consistent? The regulation of pathology testing.

In general, the regulatory requirements for IVD devices vary by region. Some of the key regulatory bodies and frameworks include:

• United Kingdom: The MHRA oversees IVD device regulation, and manufacturers need to comply with the requirements of The Medical Device Regulations 2002 (SI 2002 No 618, as amended) (UK MDR).
• United States: The Food and Drug Administration (FDA) regulates IVD devices through the Center for Devices and Radiological Health (CDRH). Manufacturers must adhere to the regulations outlined in the Code of Federal Regulations (CFR), specifically Title 21, Part 809 for in vitro diagnostic products. 
• European Union (EU): The EU regulates IVD devices through Regulation (EU) 2017/746 (EU IVDR).

The regulatory framework in other countries include:

• Canada: Medical Devices Regulations (SOR /98-282).
• Japan: Pharmaceuticals and Medical Devices Act (PMD Act).
• Australia: Therapeutic Goods Act 1989.
• Other International Standards: International standards, such as ISO standards are guidelines that provide best practices and specifications for quality management, risk management, and technical aspects applicable to IVDs. BIVDA have collaborated with BSI to develop a comprehensive list of relevant standards that relate to various aspects of IVD product development and manufacturing.

Economic operators in the IVD industry are set out in law by the EU Medical Device Regulations (MDR) and In Vitro Diagnostic Regulation (IVDR) and encompass stakeholders involved in the supply chain. These include manufacturers, importers, distributors, and country-specific authorized representatives.

While many of the responsibilities of IVD importers are universal, specific details and regulatory requirements can vary by country. In general, importers are responsible for ensuring that IVD devices entering a specific market comply with regulatory requirements. This includes verifying manufacturer adherence to relevant standards and ensure the necessary documentation, such as the Declaration of Conformity, is available. Importers contribute to the overall safety and performance of IVD devices in the market by conducting thorough assessments and taking appropriate measures to address non-compliance.

Manufacturers are classed as economic operators and hold the responsibility of delivering safe and effective IVD devices to the market. This includes designing and producing IVD devices, maintaining a Quality Management System, ensuring regulatory compliance, conducting clinical evaluations, creating technical documentation, issuing Declarations of Conformity, engaging in post-market surveillance, providing clear labelling, establishing traceability, pursuing continuous improvement, managing the supply chain, and communicating with regulatory authorities

For the regulatory submission, manufacturers typically need to provide a comprehensive set of documentation including, but not limited to, technical files, QMS documents, risk assessments, clinical data, and a Declaration of Conformity.

The role of a Notified Body and of a UK Approved Body is to conduct conformity assessment of medical or IVD devices under the relevant EU Regulations (EU MDR and EU IVDR) or UK legislation (UK MDR 2002), respectively. They play a key role in the certification process for devices marketed in the EU or UK.

The UDI system involves assigning a unique identifier to each IVD device to identify the device throughout healthcare supply chains. It enhances the accuracy of product traceability and enables medical device manufacturers and regulatory bodies to discover trends easily and respond quick to device associated risks.