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Impact of EU IVDR on Key Compliance Areas
An in vitro diagnostic (IVD) product is a reagent, instrument, or system used to diagnose diseases, or conditions, including determining a person’s state of health to cure, mitigate, treat, or prevent diseases. Typical applications of IVDs include collecting, preparing, and examining human body specimens. Like medical devices, IVDs play a critical role in patient care and management. Therefore, it is imperative to have regulations that ensure that the IVDs are safe, effective, and perform as intended.
The European Union In Vitro Diagnostics Regulation (EU IVDR 2017/746) is the new legislation that came into force on 26 May 2017. As we are approaching the deadlines for various IVDR risk classes, the manufacturers are gearing up to complete the transition activity to ensure the uninterrupted sale of IVDs in the EU market. Most OEMs have already begun and progressed to a particular stage in the implementation process. However, based on varying experiences, one can understand that remediation has not been an easy task. As a result, the transition journey has been challenging for manufacturers, service providers, and NBs alike. A few, however, have managed to overcome these challenges, as evident by the NB approvals and CE marking they have received.
Handling Critical Challenges
One of the biggest challenges the new regulation presents is the risk-based classification of devices. In the EU IVDD, most of the IVDs were self-certified, and only 10-20% were supposed to undergo NB scrutiny. The EU IVDR, on the other hand, has strict requirements, requiring NB intervention for CE marking for about 80-90% of devices. This up-classification accounts for most gaps in technical files and requires a high volume of documentation to ensure compliance. The new “risk-based” classification system has 7 rules, which are also well defined in the MDCG 2020 guidelines on classification assessment.
The reclassification of the IVDs has also led to stringent requirements for analytical and clinical data. For example, for an earlier class A device that has been up-classified to class B, all the applicable analytical parameters will be tested and verified as part of the documentation. Similarly, a class B IVD that becomes a class C due to reclassification must now be tested to validate and document clinical performance parameters. Additionally, in the EU IVDR, analytical and clinical parameters have become crucial for the performance and safety checks of IVDs. This is documented in the devices’ Performance Evaluation Report (PER). The inclusion of PER is entirely new; however, the lack of a specific guidance document for the evaluation process is another critical challenge manufacturers face.
Further, there is a lack of templates and SOPs that would guide the creation of a PER. Besides demonstrating analytical and clinical performance, scientific validity, which forms an integral part of PER, must be established as well. It is also imperative that the clinical benefits of the device are validated and its state-of-the-art demonstrated. Finally, a detailed analysis of the device’s intended use is key in determining data sufficiency.
It is evident from the revised timelines that the most complex devices have the shortest amount of time to comply with EU IVDR. Similarly, the remediation activities and the amount of documentation required, increase with the risk class. This indicates that the higher-risk devices must be prioritized. Furthermore, the remediation process must be started at the earliest if the gap assessment reveals any significant gap in verification and validation or clinical data requirements.
Moreover, the requirements for post-market surveillance activities have been expanded substantially and now include in-depth evaluations of the marked data. The requirement is not only limited to reactive data and includes proactive data in some capacity. For a higher class of devices, a vigilance process and a defined procedure for handling CAPAs and FSCAs must be established, implemented, and documented in PMSR. For each class of IVDs, PMSR must be updated at set intervals. Manufacturers, therefore, have had to implement processes for assessing and documenting market feedback and handling complaints.
The EU IVDR has broad, comprehensive, and stringent requirements for compliance. By virtue of its rigorous nature, the new regulation will ensure the safety of patients and end-users. IVD manufacturers should begin the transition process at the earliest to have their devices CE marked and maintain uninterrupted sales in the EU. The remediation process may take several months to years. So now is the time to initiate a high-level assessment to determine if there are any significant missing documents or data. The process can be efficiently carried out by partnering with external vendors and service providers. Service providers can ramp up or scale back skilled teams as and when required. They bring cross-functional teams to the table and train them to adapt to individual clients’ requirements quickly. This will fulfill the manufacturer’s need to onboard a large number of employees just for a couple of years to work on the new compliance. The partnership also allows them to continue their existing R&D activities, thus maintaining their competitive edge in the market.
Tata Elxsi has 1000+ person-years of experience providing regulatory compliance services such as consulting, technical file remediation, compliance testing, clinical evaluation, post-market surveillance, packaging, and labeling services. We address key concerns such as Brexit, submission readiness for EU Notified Body, non-EU submissions, clinical data sufficiency, post-market surveillance, and performance evaluation with our proven remote and agile-based project management in EU IVDR implementation programs. Further, Tata Elxsi’s “Compliance Assurance” model brings catalog pricing and business outcomes-based execution to maximize confidence and minimize risk in EU IVDR transition programs.