Legacy IVD devices are IVDs legally CE-marked under the old EU In Vitro Diagnostic Directive (IVDD). They were CE marked before the EU In Vitro Diagnostic Regulation (IVDR) took effect. They are allowed to remain in the market during a defined transition period if certain conditions are met. These devices bridge the gap between the old directive and the new regulation. However, manufacturers must comply with transitional requirements until full IVDR conformity is achieved. The transition from the IVDD to the IVDR marks a significant regulatory step. Hence, in this blog, we have provided a step-by-step guide to help make your legacy devices IVDR compliant.
What are legacy IVD devices?
Before diving into the process of making your legacy devices IVDR compliant, let us understand whether your device qualifies as a legacy device. Legacy IVD devices are in vitro diagnostic devices that were legally placed in the EU market under the former In Vitro Diagnostic Directive (IVDD) before the new In Vitro Diagnostic Regulation (IVDR) came into force on 26 May 2022. They are permitted to remain available during a defined transition period if certain conditions are met. These devices include those with valid CE certificates issued under IVDD and self-certified devices that were later up-classed under IVDR. However, their declaration of conformity has to be drawn up before the regulation’s application date. To qualify as legacy, the certificate must still be valid and not withdrawn. Additionally, the manufacturers must maintain agreements with a Notified Body or obtain derogations from competent authorities.
While they can continue to be marketed until deadlines that vary by risk class (e.g., Class D until 2027, Classes B and C until 2028), manufacturers must already comply with IVDR requirements for quality management systems, post-market surveillance, and vigilance. They cannot make significant changes to design or intended use without triggering full IVDR compliance. Thus, legacy IVD devices serve as a regulatory bridge, thereby ensuring continuity of supply while industry transitions to the stricter IVDR framework.
Conditions to qualify as legacy IVD
- Must have valid IVDD CE certification at the IVDR date of application.
- Certificate must not have been withdrawn by the Notified Body.
- Manufacturer must have a written agreement with a Notified Body or derogation/authorization from an EU Competent Authority before certificate expiry
Manufacturer obligations
Even during the transition to make legacy devices IVDR compliant, legacy IVD manufacturers must:
- Maintain a Quality Management System (QMS) aligned with IVDR Article 10(9).
- Fulfil post-market surveillance and vigilance requirements under IVDR.
- Avoid “significant changes” to design or intended use, which would trigger the need for immediate IVDR compliance.
Step-by-step guide to make your legacy devices IVDR compliant
1. Conduct a comprehensive gap assessment
Begin by mapping your current IVDD compliance framework against IVDR requirements to identify gaps in classification, documentation, and processes. This assessment should cover technical files, performance evaluation, labeling, and post-market surveillance obligations. Engage cross-functional teams including regulatory, quality, and clinical experts to ensure no requirement is overlooked. Document findings in a structured matrix that highlights risk areas and timelines for remediation. This step provides the foundation for a prioritized compliance roadmap.
2. Establish agreements with a notified body
Legacy devices require a formal agreement with an IVDR-designated Notified Body to maintain market access during the transition. Initiate early engagement to secure capacity, as demand for Notified Body reviews is high. Provide them with updated technical documentation and evidence of conformity under IVDD to validate legacy status. Ensure the agreement specifies timelines for conformity assessment under IVDR. This step safeguards continuity and prevents certificate lapses.
3. Upgrade quality management systems (QMS)
To make your legacy devices IVDR compliant, you must have a robust QMS aligned with ISO 13485 and IVDR requirements. Update your QMS to include risk-based processes, supplier controls, and lifecycle management. A modernized QMS not only ensures compliance but also strengthens audit readiness.
4. Implement performance evaluation and clinical evidence
Legacy devices must transition to IVDR’s stricter requirements for performance evaluation, including scientific validity, analytical performance, and clinical performance. Collect and document evidence that supports intended use, sensitivity, and specificity. Ensure documentation is structured. This step validates device safety and effectiveness under the new regulatory framework.
5. Strengthen post-market surveillance and vigilance
Under IVDR, legacy devices must comply with enhanced post-market surveillance obligations. Develop proactive systems to collect, analyze, and report device performance data in real-world use. Implement vigilance procedures for incident reporting and corrective actions. Use trend analysis to identify potential risks and feed findings back into risk management. This ensures continuous compliance and builds trust with regulators and healthcare providers.
6. Update technical documentation and labeling
Revise your technical documentation to meet IVDR requirements, ensuring completeness and traceability. This includes detailed device description, intended purpose, design and manufacturing information, and performance evaluation data. Update labeling and Instructions for Use (IFU) to reflect IVDR-specific requirements, such as Unique Device Identification and risk classification. Ensure translations and language requirements are met for all EU member states where the device is marketed. This step guarantees transparency and regulatory alignment across documentation and labeling.
7. Strengthen supply chain and economic operator compliance
IVDR places obligations not only on manufacturers but also on importers, distributors, and authorized representatives. Establish clear contracts and compliance monitoring systems for all economic operators in your supply chain. Verify that distributors and importers fulfill their responsibilities for traceability, complaint handling, and regulatory reporting. Implement supplier audits and risk-based oversight to ensure conformity throughout the supply chain. This step ensures that legacy device IVDR compliance is not limited to the manufacturer but extends across the entire distribution network.
8. Prepare for audits and regulatory inspections
Develop audit readiness frameworks that align with IVDR expectations for documentation, QMS, and vigilance systems. Conduct internal mock audits to identify weaknesses before official inspections by Notified Bodies or Competent Authorities. Train staff on audit protocols, evidence presentation, and corrective action processes.
Need to make your legacy devices IVDR compliant
- Patient safety and public health: Making your legacy devices IVDR compliant ensures that they are rigorously tested, validated, and monitored, thereby reducing risks of inaccurate results or unsafe products. By meeting regulatory standards, manufacturers protect patients from harm caused by faulty diagnostics or unreliable devices.
- Market access and business continuity: Without compliance, devices cannot legally be sold or distributed in regulated markets, such as the EU. Achieving conformity under frameworks like IVDR allows manufacturers to maintain uninterrupted access to hospitals, labs, and healthcare providers. This continuity is critical for sustaining revenue streams and protecting long-term business viability.
- Trust and reputation: Compliance demonstrates a manufacturer’s commitment to quality, transparency, and accountability. Healthcare providers and patients are more likely to trust companies that adhere to strict regulatory standards.
- Legal and financial protection: Non-compliance can lead to penalties, product recalls, or bans from the market, which can be financially devastating. Regulatory adherence minimizes exposure to lawsuits and liability claims. By proactively complying, companies protect themselves from costly disruptions and legal consequences.
- Innovation and global competitiveness: Compliance frameworks push manufacturers to adopt advanced quality systems, risk-based approaches, and continuous improvement. This fosters innovation while ensuring new technologies meet safety and performance standards.
Pharmadocx Consultants will help you make your legacy devices IVDR compliant
Our end-to-end IVDR compliance service will efficiently transition your legacy devices to IVDR compliance within the stipulated deadline. Additionally, we offer comprehensive CE marking service to our clients. Drop an email at [email protected] or call/Whatsapp on 9996859227 to easily make your legacy devices IVDR compliant.
