By Hilde Viroux and Hans Mische, PA Consulting
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 The 23 include five notified bodies from the U.K. that have had their designation withdrawn because of Brexit.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?
- Select and contract with an IVDR designated notified body. Notified bodies are not necessarily designated for all types of IVDs, so the first step should be to compare your product portfolio with the designated scope of the notified body to ensure there is a match. You can search the NANDO website of the European Commission or check directly with the notified body to verify that they will be able to assess all your IVDs.
- Assess and prioritize your product portfolio. With all the work that needs to be done to bring product documentation up to date, it is advisable to look at the total cost of compliance. For some products, the cost of remediation may be higher than the sales value, so you should take a holistic look at the sales and product value before starting remediation efforts. Similarly, bearing a possible bottleneck with the notified bodies in mind, a company may prioritize the remediation of products that deliver the highest sales value to ensure they can stay on the market after May 2022.
- Get the necessary tools and communications in place. Implementing IVDR is a major undertaking, affecting all areas of the business. Managing such a program in a normal pre-pandemic environment was already a challenge. With the majority of the workforce working from home during the pandemic, even more time has to be spent on training, communication, and change management. Change management was important before, as people often resist change. With the physical separation adding to the challenge, it is critical that the necessary tools and communications are in place to get people motivated and aligned to the changes.
- Coordinate between your various workstreams to align your activities. This is vital to ensure that the inputs to the technical documentation, QMS, labeling, etc. are accurate and timely. A dedicated multifunctional team is needed to align the tasks and review the technical documents. In many cases, new processes and procedures will need to be initiated. To increase efficiency and reduce costs, product documentation and labeling updates to IVDR should coincide with scheduled revisions to avoid extra work. Rolling out IVDR compliant labeling needs careful planning between the regulatory function for global registrations, manufacturing, and supply chain for inventory management.
- Update your technical documentation, including additional testing and creation of new reports like Performance Evaluation Plans and Reports, Periodic Safety Update Reports, and Design History File. This represents a significant amount of work, and testing can take a long time to complete.
- Establish a compliant supply chain. This expansion of the scope of the legislation should not be underestimated. For companies with a complex distribution chain, it can already be a challenge to map out the supply chain and product flows to identify the various economic operators. The role of an economic operator can vary on a product-by-product basis. Importers and distributors have to perform checks, but the checks vary with the role of the economic operator. Distributors that translate the instructions for use or repackage products must meet specific requirements and require a notified body inspection for these activities. Adopting economic operator compliance early on as part of the overall compliance program reduces the risk of running out of time toward the May 2022 due date.
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.
About the Authors:
Hilde Viroux is a medtech expert at PA Consulting and a leading expert on the European Medical Devices Regulation. She is a senior leader with a broad experience in regulations, quality, manufacturing, supply chain, and project management in the pharmaceutical and medical device industry. She has an outstanding track record on successful implementation of major projects and building up new capabilities within an organization. She has an MSc in Medical Technology Regulatory Affairs from Cranfield University in the U.K., and a BS in biochemistry engineering. Connect with her on LinkedIn.
Hans Mische is a medical devices design and development expert at PA Consulting. He has demonstrated expertise in business development, strategy, upstream marketing, strategic account management, product development, clinical evaluations, manufacturing, and regulatory affairs in multiple markets. Mische has held leadership roles in organizations ranging from start-ups to large multinational corporations, has experience working with all top 10 medical devices companies, and recently led a global IVDR program for a major diagnostics product company. Additionally, he founded or cofounded five medical device companies and is an inventor on 50+ issued patents for various medical device and diagnostic devices, systems, and technologies. He has a BS in Physics from Saint Cloud State University. Connect with him on LinkedIn.