The European Union In Vitro Diagnostic Regulation (EU IVDR 2017/746) has transformed the medical device industry. Replacing the In Vitro Diagnostic Directive (IVDD 98/79/EC), the IVDR establishes more rigorous standards to enhance the safety, performance, and quality of in vitro diagnostic medical devices (IVDs).
However, the transition from IVDD to IVDR can be complex and manufacturers of legacy devices must navigate a range of considerations to ensure compliance while adapting to the new regulatory landscape.
Maintaining Regulatory Compliance During the IVDD-to-IVDR Transition
To facilitate a smooth transition, IVDD-compliant legacy devices may continue to be placed on the market until the following deadlines:
- Class D devices: Compliance required by 31 December 2027.
- Class C devices: Compliance required by 31 December 2028.
- Class B and Class A sterile devices: Compliance required by 31 December 2029.
These extended timelines aim to provide manufacturers with the opportunity to adjust to the IVDR. However, continuing to market legacy devices during this period is conditional upon strict adherence to specific requirements.
Conditions for Placing IVDD-Compliant Devices on the Market
Legacy devices may remain on the market during the transition period only if the following conditions are met:
- The device must remain fully compliant with the IVDD.
- There are no significant changes to device design or intended purpose.
- The device does not present an unacceptable risk to patient or user health and safety, nor to public health.
- By 26 May 2025, the manufacturer must have implemented a Quality Management System (QMS) in accordance with Article 10(8) of the IVDR.
- A formal application must have been lodged with a notified body (as per section 4.3, Annex VII) for conformity assessment no later than the 26 May 2025 for Class D devices, 26 May 2026 for Class C devices, and 26 May 2027 for Class B and Class A sterile devices.
- The manufacturer must have written agreement with the Notified Body by 26 September 2025 for Class D devices, 26 September 2026 for Class C devices, and 26 September 2027 for Class B and Class A sterile devices.
Failure to meet these conditions will negate compliance under transitional provisions.
Implementing an IVDR-Compliant QMS
Having an IVDR complaint QMS in place is not just about meeting regulatory requirements; it is a proactive strategy to ensure the continuous safety and performance of an IVD in a competitive market. To meet IVDR requirements, the QMS must include the following elements:
- A strategy for regulatory compliance, including management of modifications to devices.
- Identification of safety and performance requirements and strategies to address them.
- Clear management responsibility and accountability.
- Resource management, including oversight of suppliers and subcontractors.
- Comprehensive risk management in line with Annex I, Section 3.
- Performance evaluation, including Post-Market Performance Follow-up (PMPF) per Article 56 and Annex XIII.
- Processes for product realisation, from design and development to production and service.
- Verification of Unique Device Identifier (UDI) assignments and consistent device information management under Articles 24(3) and 26.
- A robust Post-Market Surveillance (PMS) system, as outlined in Article 78.
- Effective communication with stakeholders, including authorities, notified bodies, and customers.
- Processes for reporting serious incidents and implementing corrective and preventive actions (CAPA).
- Monitoring, measurement, and continuous product improvement.
An IVDR-Compliant QMS for Legacy Devices
Manufacturers must ensure their QMS is aligned with IVDR regulatory requirements. However, for certain aspects outlined in Article 10(8), such as points (b), (e), and (f), a distinction must be made for “legacy devices”. For these devices, manufacturers are not required to have identified all relevant safety and performance requirements, implemented comprehensive risk management, or conducted a full performance evaluation. However, it is important to note that from the 26 May 2025, manufacturers must ensure that their QMS addresses how compliance with these requirements will be achieved for legacy devices, ensuring full alignment with IVDR standards.
Manufacturers have a few strategic options for updating to an IVDR-compliant QMS. One approach is to establish a parallel QMS. This approach enables clear reference to the appropriate procedures and highlights the transition to the new system. For companies with complex, long-standing QMS, it offers the chance to streamline and enhance efficiency. However, this approach demands considerable effort to develop and eventually replace the old procedures.
Alternatively, companies whose existing QMS already aligns closely with the new IVDR requirements might prefer to update their current system. While this option can be more efficient, it may present challenges in ensuring that certain QMS elements are applied consistently across all products.
Despite the chosen approach, documenting the transition is critical, clearly defining which procedures apply, when they take effect, and which products they impact. This can be done either within the procedures themselves or through a separate project plan. In addition, comprehensive training is key to ensuring everyone involved understands and implements the new requirements effectively.
The Time to Act Is Now
As the transition deadlines approach, manufacturers of legacy IVDs need to act swiftly to remain competitive and compliant in the evolving European market. The IVDR represents a major overhaul of IVD regulation in the EU, but it aims to ensure medical devices are safer, more effective, and of higher quality. Manufacturers who embrace these changes and take proactive steps to comply will be better positioned to navigate the evolving regulatory environment, ensuring continued market access and patient safety.
Struggling with your IVDD to IVDR transition? Mantra Systems is here to help! Our expertise can guide you through the complexities of achieving IVDR compliance and ensure your QMS is up to date with the latest regulatory requirements. Contact us today.
