The in vitro diagnostic devices industry has until May 25, 2022 to bring products, documentation, and quality management systems into compliance with the new EU Regulation on In Vitro Diagnostic Devices 746/2017 (IVDR). This regulation is a major revision, focusing on patient safety, requiring more clinical evidence, improving traceability in the supply chain, and enforcing a proactive post-market surveillance system to ensure early detection of problems.
The past year presented a challenge in implementing the IVDR while the COVID-19 pandemic forced the industry to focus efforts on bringing COVID-19 tests to the market. The May 2022 deadline is quickly approaching and there is no sign that the EU Commission is considering postponing it. Even if the deadline is pushed back, the expectation is that it would only be for a year, similar to the extension granted for the medical devices regulation. Full compliance programs often take longer than that. Companies that haven’t started their compliance journey need to act soon, as the majority of the IVDs currently on the market cannot be sold after May 2022 unless they are in full compliance with the regulations.
Challenges Implementing IVDR Compliance
The challenges of ensuring IVDR compliance are mostly related to products having insufficient design documentation, requiring additional testing and performance evaluations that must include scientific, clinical, and analytical data – the list goes on. Coordinating the documentation updates between the various functional areas and arranging tests while many staff members work from home due to COVID-19 brings an additional layer of complexity. The fact that most IVDs did not involve the oversight of a notified body under the current IVD directive contributes to the product documentation often not being up to par.
This leads to the second challenge for IVD companies: Not only are many companies not used to working with a notified body, but there are still not enough notified bodies designated under IVDR to cover all the IVDs currently on the market in the EU. IVDR will require notified body involvement for about 80% of the IVDs, compared to less than 20% of IVDs under the current directive. As of early February 2021, there are four notified bodies designated under the IVDR, compared to 23 notified bodies under the IVD directive. The 23 include five notified bodies from the U.K. that have had their designation withdrawn because of Brexit. A simple calculation shows the bottleneck that is coming. The four notified bodies designated under IVDR will be expected to deal with four times as many products as the 23 notified IVD bodies have. And experience from manufacturers dealing with notified bodies for MDR compliance shows that the notified bodies don’t have the resources to deal with the increased demand and requirements, which is having a negative effect on delivery of the services and timelines.
In addition, the notified bodies must perform on-site audits to verify the manufacturer’s quality management system. The EU Commission has opened the door to remote audits, but the final decision to allow remote audits is with each country overseeing the notified body, which may lead to discrepancies in the approach to remote audits between notified bodies.
What Steps Should You Take To Meet The IVDR Deadline?
IVDR implementation brings many challenges but also gives companies the opportunity to rationalize and optimize their product portfolio, streamline the supply chain, and implement more robust design and QMS processes to ensure safer products and continued sales in the EU.
Hilde Viroux is a medtech expert at PA Consulting and a leading expert on the European Medical Devices Regulation. Hans Mische is a medical devices design and development expert at PA Consulting.