IVDR is the new regulatory framework to ensure the safety and performance of in-vitro diagnostic medical devices (instruments, reagents, or systems). IVDR meaning the test used to determine a person’s health status by looking into their biological sample. There are a wide variety of these devices, including allergy tests, intolerance tests, and vitamin D tests, among other varieties of tests.
Since May 26th, 2022, IVDR has replaced the EU’s Directive on in vitro diagnostic medical devices (IVDD 98/79/EC). As a European regulation, it is now effective in all countries that are members of the EU and the European Free Trade Association (EFTA). Those not members, including the UK but not Northern Ireland, require a European Representative to register and market their medical devices within the EU.
The main goal behind IVDR regulation is to ensure a high level of patient safety and public health. It also considers scientific progress and smooth operation when it comes to selling these products in the market.
Why did IVDR regulation change?
One of the largest industries within the healthcare sector is medical devices. This has been driven by the perpetual progress and introduction of new innovative technologies resulting in state-of-the-art medical devices’ development and significant growth. Medical device regulation was created in the 1990s, and due to the growth of the industry and the science behind it, rules to improve the safety of these devices needed to be revised.
At-home testing devices are the more futuristic healthcare innovations that are becoming standard practice changing the way medical diagnoses are performed and reshaping the world of healthcare. The covid pandemic made various lab tests at home advantageous and prompted new engaging testing methods, including a range of lateral flow, breathalyzers, skin patches, microbiome, and genetic biomarker tests.
This has also led to the direct-to-consumer (DTC) market overtaking the over-the-counter (OTC) market and is now becoming prominent in clinical practices. At-home testing is either instant results or a sample taken at home and posted to an appropriately certified laboratory. You can find safe at-home health tests at Test Your Intolerance.
IVDR was introduced for various reasons, including the need to bring legislation in line with the expeditious pace of technological advances and the current rapid evolution of science. The new IVDR aims to enforce accountability, transparency, and traceability within the medical device world by requesting performance evaluation reports covering scientific validity, analytical performance, and clinical performance.
Conformity assessment bodies (‘notified bodies’), for example, EUMED (European Database on Medical Devices), subsequently play a more important role under the new IVDR, independently monitoring whether devices comply with general safety and performance requirements (GSPR) before they are launched on the EU market with an approved CE (Conformity European) logo.
What are the changes?
IVDR has introduced substantial changes and stricter requirements to medical device regulations. Meaning around 80% of IVD products, as opposed to the prior 20%, previously did not require involvement from Notified or Certified Bodies as they were classed under IVD as “self-declared” devices, which meant the manufacturer assessed the conformity of the product themselves. However, these will now need evidence reviewed by the appropriate official bodies.
Other critical changes include the following:
- Revised reclassification of devices according to the risk imposed on users {1}. This classification includes class A as low individual and public risk and class D being high risk for both.
- Highly rigorous clinical evaluation, mostly for higher-risk classes of device.
- Self-testing and near-patient testing devices will be subject to pre-market approval.
- Identification of ‘person responsible for regulatory compliance (PRRC).
- Implementation of unique device identification (UDI) for ensured traceability.
- Genetic testing must now include their significance and implications alongside access to expert genetic counselling.
Most existing medical devices have moved up into a higher-risk class under the new IVDR regulations to adhere to.
What’s the impact of IVDR medical device regulation?
The transition from IVDD to IVDR has made the development process more complex and time-consuming. There is also extensive third-party involvement and increased expenses for device manufacturers. However, medical device clinical evaluation will improve the standards and performance of IVD devices or force negligent manufacturers to withdraw poorly performing or below-standard devices from the European market.
However, some manufacturers may withdraw devices due to expense or impossible production development limitations, especially smaller innovative companies. Despite the stricter and more complex regulation requirements, manufacturers must recognize this and wait to transition to the new IVDR before seriously threatening their market positioning and will inevitably lose out. IVDR or a similar equivalent is a permanent change and will soon become the new norm globally.
Because at-home testing is here to stay and the old IVDD list-based classifications were no longer fit for purpose, IVDR will excel in global standards, require premium performance and enforce the paramount safety of medical devices vital to future healthcare.
Read more allergy and intolerance testing insights via our blog.
References
- Classification of IVD under the IVDR. AKRN. (https://akrnconsulting.com/classification-ivd-under-ivdr/)
