The In Vitro Diagnostics Regulation (IVDR) — which goes into effect on May 26, 2022 — will have a lasting impact on the entire in vitro diagnostics (IVD) lifecycle, from development through clinical investigations and regulatory approval.
To comply with the IVDR, manufacturers must ensure proper technical documentation, conformity assessments, quality management requirements and post-market surveillance (PMS), in addition to maintaining evolving relationships with and responsibilities to notified bodies (NBs). More importantly, they will need to adopt a transition strategy to address gaps in meeting the new regulation.
In this blog, we will discuss:
- placing a greater emphasis on PMS under the new regulation to ensure positive results;
- implementing a successful transition strategy, which includes conducting a gap analysis;
- defining a remediation plan; and
- establishing best practices for technical file assembly and delivery.
Placing a higher emphasis on PMS and vigilance under the new regulation
While previous directives for IVD products already on the market compelled manufacturers to conduct PMS, under the IVDR, the requirements will be more rigid and include new rules, such as confirming scientific validity. As a result, IVD manufacturers will have to prepare a PMS strategy for each device.
Additionally, manufacturers will need to conduct a post-market performance follow-up to confirm the safety, performance and scientific validity of a device while on the market, which includes the benefit-risk ratio and any new emerging risks or changes in the use of the device. The benefit-risk analysis introduces a higher level of requirements for IVD manufacturers, such as the identification of predicted misuse, mitigation of risks and communication of any possible risks to the user.
Also, evaluating the performance of devices needs to be continuous throughout the lifecycle, especially as updates develop from scientific or clinical practice. This allows for manufacturers to implement and monitor any correction or preventive actions and processes for their IVDs.
Executing a successful transition strategy
To effectively comply with IVDR quality management system (QMS) requirements, manufacturers will need to update or develop new standard operating procedures (SOPs). More importantly, they will need to deploy cross-functional teams with a deep understanding of device-specific requirements, coupled with experienced project execution. Once a team is established, the first step for a successful transition to the IVDR will be conducting an extensive gap assessment to identify any glaring issues, and evaluating and prioritising product portfolios and all QMS processes.
Planning and implementing technical file remediation
After updating/creating new SOPs, identifying gaps and evaluating portfolios, IVD manufacturers will need to define a remediation plan to create the required records for compliance and to consider the cost for remediation activities. Once a plan is implemented, they will have to update the QMS, the design history file (DHF) and the device master record, as well as assess whether technical file remediation is necessary.
Moreover, in addition to PMS plans and post-market performance follow-up reports (referenced above), IVD manufacturers may need to create periodic safety update reports, along with a summary of safety and clinical performance. Additionally, sponsors will need to gather data, which should be submitted to the European Databank on Medical Devices, as well as begin audit preparation. And lastly, manufacturers will have to manage the IVD lifecycle by maintaining the DHF and technical files.
Establishing best practice for technical file assembly and delivery
For successful technical file assembly and delivery, IVD manufacturers should consider partnering with an external CRO partner with extensive experience and a holistic approach to conducting a regulatory assessment and remediation program that complies with the IVDR. Specifically, they should choose a partner who has cross-functional subject matter expertise on template development and training for best documentation practices, and extensive experience in the following areas:
- Authoring performance evaluation reports
- Conducting literature searches, including developing protocols such as search strategies, screening, data extraction and reporting
- Authoring technical files, in addition to documenting assembly and submission
Next, IVD manufacturers should work with their CRO partner to establish a select team that meets regularly to review project updates, discuss challenges and implement solutions, and review budget and forecasting. Also, they should implement a governance model for the purpose of establishing priorities and responsibility. This will increase the chances of successfully meeting all initial pilot and full program requirements and deadlines. And finally, manufacturers should develop a working timeline to remediate and review all technical files for submission to an NB for review.
Despite the number of challenges, it is unlikely that the implementation of the IVDR will be delayed. For the best outcomes, IVD manufacturers will need to act now. That is why it is imperative that they develop a thorough understanding of their product portfolios, capabilities and potential losses to comply with the IVDR. By taking a holistic approach, which includes identifying gaps, defining a remediation plan to create the required records for compliance, and developing a PMS strategy and post-market follow-up, manufacturers can minimise problems and increase their chances of successful compliance.
To learn more about how to best comply with the IVDR, read our latest white paper.