With the updated in vitro diagnostic medical devices (IVD) classification moving at least 80% of IVDs under Notified Body scrutiny (compared to 20% previously!), most manufacturers should now be gearing up to shift from self-certification to notified body oversight as we enter into the third year of the In Vitro Diagnostic Regulation’s transition period.
A crucial issue manufacturers need to assess is whether they have the necessary clinical evidence to comply with the regulation.
Due to a lack of previous experience with notified bodies, and a perception that there is still a lot of time before the transition period ends in 2022, some manufacturers are underestimating how much evidence is now required to support the safety and performance of their device(s).
The new IVD classification system is based on defined risk-based categories, where ‘A’ is low risk and ‘D’ is high risk; higher risk entails greater requirements for clinical evidence as well as greater oversight from a notified body.
The challenge for legacy products is that grandfathering is not an option, meaning that each device must be re-assessed according to the level of risk.
According to the IVDR, clinical evidence must support the intended purpose of the device as stated by the manufacturer and 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.
• How much research has been conducted in relation to the device and its intended purpose?
• How robust are the results of proof of concept studies?
• What technology is the device based on?
• Which tests have been carried out?
• Which standards were used for these tests?
• Are these standards harmonized?
• How much-recorded evidence exists?
• Have clinical performance studies and tests been performed to prove the device is safe and effective?
Manufacturers must hone into these three elements and determine how much data is available to adequately answer these questions, before considering how much activity is needed to fill the gaps.
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.
Planning for this should include a financial feasibility appraisal as additional performance studies will require resources, and setting up a contract with a notified body is an additional cost, especially if multiple devices need to undergo certification. This may mean some older IVDs are retired rather than improving the technical documentation to meet the requirements of the IVDR.
Moreover, we believe that there must be a change in mentality and approach going forward, in order to make a smooth transition to the new regulation.
From our perspective once notified bodies begin to acquire designation under the IVDR, the most proactive manufacturers will be well-positioned to achieve compliance before competing companies, keeping their products on the market. There will be a race to get ahead of the queue for notified body attention; now is the time to secure a place.
This blog is part of the MedTech Forum blog series. David Egbosimba and Peter Rose, will be speaking at the MedTech Forum and Global MedTech Compliance Conference 2019. You can follow the conversation under #MTF2019 and find more details at medtechforum.eu.