Delays are temporary, IVDR is permanent: are you ready to meet the requirements?

Dr. Shankar Pattabhiraman, Clinical Flow Cytometry Senior Technical Product Manager at Beckman Coulter Life Sciences provides a check list of what to consider. 

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Five things manufacturers and laboratories must do now to meet IVDR compliance before the deadline. 

The In Vitro Diagnostic Regulation (IVDR), which went into effect in 2017, creates a robust and transparent framework of rules that improve clinical safety and reduces the risk of discrepancies in interpretations across the EU. It introduces stricter regulations for medical devices, lab tests, and assay kits, and for the first time, covering in-house laboratory-developed tests (LDTs). Manufacturers and laboratories were expected to be compliant by May 2022. 

While it was never expected to be easy for manufacturers and laboratories to achieve compliance within the five-year time frame, the COVID-19 pandemic created another challenge in the marathon toward compliance to meet the 2022 deadline. As a result, last year the EU gave an extension on the time limit for IVDR compliance. Laboratories have until May 2024, whereas manufacturers have an additional two to three years for implementation. 

This update only applies to the date, not the regulation; all devices and tests must still meet the elevated standards—or risk being barred from the EU market. With just under one year until the 2024 deadline, laboratories and manufacturers must start their IVDR compliance marathon now before time runs out. Here are five ways to get started. 

1. Understand the changes from the old requirements 

A major weakness of previous requirements was that it categorized the level of regulatory scrutiny for IVDs based on a predetermined list of diseases and medical conditions. Because of this, the IVDD was unable to respond to new and emerging diseases effectively, and a majority (93.1%) of all medical devices and tests were regulated at the lowest risk level. The IVDR fixes this issue by introducing a classification system based on risk. All devices and tests will be categorized using a 4-tier system. Only the lowest-risk tier will have fewer requirements, while all devices and tests in the other tiers will enforce more stringent regulations for quality and traceability. Using this “risk, not list” approach, only an estimated 15% of all devices will fall into the lowest risk category. On the other hand, 85% of all devices and tests are expected to be classified under the higher-risk categories with stricter requirements. 

The new requirements for IVDs include compulsory certification by a notified body, increased requirements for clinical evidence and performance evaluation, improved traceability, and a new requirement for post-market surveillance after product launch. Laboratories running LDTs will also need to follow a system to ensure home-brewed tests meet the same quality standards as IVDs. Understanding these new IDVR requirements is crucial for submitting successful applications. 

2. Evaluate the resources needed to meet compliance 

With these new requirements, IVD manufacturers will need to allocate substantial resources to prepare for and obtain compliance. The required risk management, quality assessment, post-market surveillance, and budget plans will take a significant amount of time to complete. Manufacturers will also need to conduct a variety of studies to demonstrate the performance of their IVDs. Because of this need for more data and documentation, manufacturers should re-evaluate their quality management systems (QMS). Many of these assessments also carry nuances that require qualified personnel to comprehend. Through proper planning, IVD manufacturers can prepare high-quality applications and minimize the chances of rejection. 

3. Submit applications to notified bodies early 

Interestingly, the IVDR significantly reduced the number of notified bodies qualified to review and certify IVDs. There are currently only 10 notified bodies designated by the IVDR. These few notified bodies are tasked with reviewing a massive number of applications across the EU. Since the review process will take time and additional information may be requested, manufacturers must prepare the necessary documents and submit applications as soon as possible to avoid a potential backlog and allow products to meet company timelines. 

4. Decide between switching to certified IVDs or continuing with LDTs 

Although manufacturers have significant hurdles to overcome to get their IVDs to reach compliance, clinical laboratories running tests developed and validated in-house will also need to make changes. Labs will need to switch to certified IVDs or meet additional requirements if they wish to continue using home-made LDTs. If laboratories wish to continue using LDTs, they must follow the same regulations as manufacturers—including those previously mentioned. This will undoubtedly be a heavy burden for laboratories to take on, since most do not have the resources or expertise that large manufacturers do. In these situations, labs should determine whether a suitable commercially-available certified IVD is already available on the market to use as a substitute. If the certified IVD alternative is not available, the laboratory should seek help from manufacturers and ask if specific IVDs are planned or in the pipeline for certification. 

This decision should not be taken lightly. Laboratories should choose their course of action only after conducting comprehensive market research to identify which tests they can replace with IVDs or keep producing themselves, and how this fits into their budget. 

5. Determine if your LDT can be partially exempt from IVDR compliance 

Some laboratories may find themselves in a situation where they must continue to produce and use their own tests because no suitable certified IVD alternatives are on the market. This is often the case with rare diseases where a commercially-available test has not yet been developed. In these situations, these LDTs can be partially exempt from some IVD regulations if they meet the following criteria (Article 5.5): 

  • They must be a European health institution 
  • They must comply with the general safety and performance requirements (GSPR) described in Annex I 
  • They must have a compliant quality management system 
  • They must successfully demonstrate that suitable certified IVD alternatives are not available to obtain the same diagnostic results 

Regardless of the scenario, all EU laboratories will need to make changes. Even if a laboratory can find a suitable certified IVD to replace an LDT, staff will still need to conduct validations, update protocols and equipment, or improve quality management systems to use the new test. Therefore, carefully considering the consequences of each decision will aid in a successful transition to IVDR. 

Looking Ahead 

The IVDR marathon is undeniably challenging for both manufacturers and laboratories. But the end result will be a win-win situation for all parties. Patients will benefit from more accurate diagnostics. By raising the standard for quality and risk management, the IVDR will improve the safety of IVDs and LDTs across the board, minimizing life-threatening inaccuracies to protect patients. Similarly, manufacturers and laboratories will reap rewards from the creation of fair market access. While the world is watching how this transition will go, companies can continue to launch products in the EU, and both manufacturers and labs will improve consumer confidence and stand out from the competition. IVDR compliance needs to be taken seriously, and manufacturers and laboratories need to act now to reach the finish line.