Are clinical trials necessary for products under Invitro Diagnostic Regulation

In vitro diagnostic medical devices are tests conducted on biological samples to find out the condition of a person in regards to specific disease. The range of Invitro Diagnostics (IVDs) are vast, with the radius starting from self-tests for pregnancy and blood glucose tests for diabetics, to sophisticated diagnoses performed in clinical laboratories. 

With the updated IVD classification, 80% of the IVDs falls under Notified body’s scrutiny (compared to 20% previously!), most manufacturers should now gear up to shift from self-certification to notified body oversight.

The new In Vitro Diagnostic Regulation (IVDR) aims to harmonise regulatory framework across the European Union (EU) to ensure the safety and performance of devices by placing greater responsibility on manufacturers to demonstrate that their products meet stringent requirements. A crucial issue manufacturers need to assess is whether they have the necessary clinical evidence to comply with the regulation.

Because of the reclassification of IVDs under IVDR, different device categories now require different levels of documentation. Clinical evidence is very much required for approval. Additionally, with no excuse for previously certified devices, each device should be re-assessed based on the new classification, manufacturers will need to determine how relevant currently available data is for devices already on the market.

According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and should be based on a continuous process of performance evaluation, following a performance evaluation plan.

Performance evaluation reports should demonstrate the following elements: scientific validity; analytical performance; and clinical performance.

Scientific validity:

a) How much research has been conducted in relation to the device and its intended purpose?

b) How robust are the results of proof of concept studies?

c) What technology is the device based on?

Analytical Performance:

a) Which tests have been carried out?

b) Which standards were used for these tests?

c) Are these standards harmonized?

d) How much-recorded evidence exists?

Clinical Performance:

a) Have clinical performance studies and tests been performed to prove the device is safe and effective?

The data for these three key areas, their assessment and the related clinical evidence must be documented in the performance evaluation report, and this needs to be kept up to date throughout the life cycle of the device.