The European Union’s In Vitro Diagnostic Regulation (IVDR) (EU 2017/746) significantly changed the regulatory environment for in vitro diagnostic (IVD) devices. With stringent requirements for clinical evidence, post-market surveillance, and performance evaluation, manufacturers face challenges in ensuring compliance, particularly for legacy devices—products that were previously certified under the In Vitro Diagnostic Directive (IVDD) (98/79/EC) but are still on the market.
Managing legacy devices under IVDR necessitates a strategic approach to ensure continued functionality while transitioning to IVDR compliance. This study focusses into the effects of IVDR on legacy devices, as well as the vital function that regulatory consultants play in ensuring compliance.
Understanding Legacy Devices Under IVDR:
A legacy device is a device that was CE-marked under IVDD but has yet to be changed to EU IVDR 2017/746 compliance. These devices are eligible for a grace period that extends market access until May 26, 2025 (or later, depending on risk classification and transition extensions), provided they meet specific post-market surveillance and reporting requirements.
Key aspects of IVDR impacting legacy devices:
- IVDR’s risk-based classification system requires most devices to be reviewed by a Notified Body (NB).
- Legacy equipment must meet tighter standards for performance evaluation and clinical evidence.
- Post-Market Surveillance (PMS) – New requirements for monitoring device functioning and reporting major events.
- Economic Operator Compliance: Increased examination of producers, importers, and distributors.
Challenges in Managing Legacy Devices
- Increased regulatory burden
Manufacturers must set up and update Performance Evaluation Reports (PERs), which were not required under IVDD. Documentation revisions are required for Post-Market Surveillance Plans (PMSP) and Performance Follow-up (PMPF). - Notified body bottlenecks
The lack of designated Notified Bodies (NBs) under IVDR has resulted in an insufficient number of conformity assessments. Manufacturers may struggle to get timely clearances before the transition time. - Cost and resource constraints
Meeting IVDR requires significant investment in regulatory expertise and quality management systems. Medium-sized companies (SMEs) may lack internal resources to maintain IVDR compliance. - Supply chain disruptions
New regulatory obligations for importers and distributors may impact the availability of legacy devices. Non-compliant devices face withdrawal from the EU market.
Role of Regulatory Consultants in IVDR Compliance:
Regulatory advisors assist manufacturers in navigating the difficult IVDR compliance process for legacy equipment. Their knowledge assures smooth transfers and minimal business disruptions.
- Gap Analysis and Risk Assessment:
Consultants conduct a regulatory gap analysis to detect gaps between a legacy device’s current documentation and IVDR regulations. They assist producers in determining categorisation adjustments under IVDR regulations.
• Identify gaps in clinical evidence and provide compliance solutions.
• Assess risks associated with post-market surveillance duties.
- Technical Documentation Support
Consultants help compile and update technical documentation to meet IVDR’s demanding requirements. Legacy devices are required by IVDR to submit a Performance Evaluation Report (PER) that includes:
- Scientific Validity Reports
- Analytical performance data and clinical studies.
- Risk-benefit analysis
- Communicating with Notified Bodies
Given the scarcity of Notified Bodies, advisors help to smooth out connections, ensure timely submissions, and answer NB remarks quickly. Their competence reduces the likelihood of application rejection or extended review durations.
- Post-Market Surveillance and Vigilance
Consultants assist in developing strong PMS and PMPF activities by implementing effective data collecting and analysis procedures.
- Creating complaint handling and reporting procedures.
- Ensured EUDAMED database compliance for post-market reporting.
- Economic Operator Compliance
IVDR requires stronger regulation of economic operators such as manufacturers, authorized representatives, importers, and distributors. Consultants assist with:
- Ensuring all parties understand their regulatory responsibilities.
- Assist with audits and inspections by competent authorities.
- Create Standard Operating Procedures (SOPs) for compliance.
- Training and continuous compliance support
Consultants offer regular training and compliance updates for the ever-changing IVDR regulatory framework, keeping regulatory teams informed of new standards.
- All departments understand their duties in ensuring compliance.
- Risk mitigation techniques are regularly updated.
Conclusion :
Handling legacy devices under IVDR is a challenging task that forces manufacturers to reconsider their compliance strategy. The transition period is limited, and failing to achieve IVDR requirements may result in the market removal of critical diagnostic devices.
Regulatory consultants play a critical role in assisting manufacturers in eliminating the compliance gap by providing technical expertise, documentation support, risk assessment, and regulatory strategy development.
Their guidance guarantees that legacy devices stay operational while shifting to the IVDR design. Manufacturers should proactively engage regulatory specialists to effectively navigate the IVDR landscape, guaranteeing continuing market access and regulatory success in the European Union.