Class based deadlines and what they mean for supply

The European Union's regulatory landscape for in vitro diagnostic medical devices (IVDs) continues to evolve. Regulation (EU) 2024/1860, which amends Regulation (EU) 2017/746 (the IVDR), introduces significant adjustments to the transition periods and EUDAMED requirements. This regulation aims to facilitate a smoother implementation of the IVDR, particularly regarding the phased availability of the European database on medical devices, EUDAMED.

#Extended Transition Periods for IVDs

Regulation (EU) 2024/1860 maintains and clarifies the extended transition periods for legacy IVDs. These extensions are crucial for ensuring the continued availability of essential devices on the market. Devices placed on the market under Directive 98/79/EC (IVDD) may continue to be made available under certain conditions.

Article 110(3) of the IVDR, as amended by Regulation (EU) 2024/1860, outlines the specific dates. These dates are dependent on the risk class of the device:

• 31 December 2027: For high-risk devices, specifically Class D IVDs.
• 31 December 2028: For medium-high risk devices, specifically Class C IVDs.
• 31 December 2029: For lower-risk devices, specifically Class B and Class A sterile IVDs.

Devices that do not require conformity assessment by a notified body, other than for Class A sterile devices, must comply with the IVDR from 26 May 2022. This includes non-sterile Class A IVDs.

#Conditions for Legacy Devices

For a legacy device to benefit from these extended transition periods, several conditions must be met, as specified in Article 110(3a) of the IVDR:

1. The device must comply with Directive 98/79/EC.
2. There must be no significant changes in the design and intended purpose of the device.
3. The device must not pose an unacceptable risk to health or safety.
4. The manufacturer must have established a quality management system in accordance with Article 10(8) of the IVDR by 26 May 2025.
5. The manufacturer must have submitted an application for conformity assessment to a notified body by 26 May 2025, for devices requiring notified body involvement.
6. A written agreement between the manufacturer and the notified body must be in place by 26 May 2026.

These provisions are analogous to those for medical devices under the MDR. Further details on conditions for extended transition periods can be found in our article: Conditions attached to the extended MDR transition period.

#EUDAMED Rollout and Obligation Dates

Regulation (EU) 2024/1860 introduces a phased rollout for certain EUDAMED modules, ensuring a more gradual implementation for economic operators. This approach acknowledges the complexity of the database and its various functionalities.

The EUDAMED modules addressed by Regulation (EU) 2024/1860 include:

• Actor Registration (Article 31 IVDR): This module facilitates the registration of manufacturers, authorised representatives, importers, and notified bodies.
• UDIR (Unique Device Identification, Device Registration, Article 26 IVDR): This module is for the registration of devices and their UDI.
• Notified Bodies and Certificates (Article 52 IVDR): This module concerns the registration of notified bodies and the certificates they issue.

#Mandatory Use Dates for EUDAMED Modules

The regulation specifies staggered mandatory use dates for these modules. These dates are contingent on the European Commission's declaration of full functionality. Once the Commission publishes a notice in the Official Journal of the European Union declaring the module fully functional, the following timelines apply, as per Article 110b of the IVDR:

It is imperative for economic operators to monitor the official communications from the European Commission regarding the declaration of full functionality for each EUDAMED module. The exact dates for mandatory use will depend on these declarations. Until these modules become mandatory, the corresponding national requirements remain applicable.

#Obligations for Distributors and Importers

Distributors and importers play a critical role in the supply chain and must ensure their compliance with the IVDR and its amendments. Article 13 and Article 14 of the IVDR outline their general obligations. Regulation (EU) 2024/1860 directly impacts these roles by modifying the EUDAMED requirements.

For example, importers must verify that the manufacturer has assigned a UDI to the device, where applicable, and that they have registered themselves in EUDAMED. Distributors must also ensure that devices they make available on the market comply with the IVDR, including checking for UDI application and manufacturer registration.

#Impact on Supply Chain Management

The extended transition periods and phased EUDAMED rollout require careful supply chain management. Economic operators must identify which of their devices are legacy devices and ensure all conditions for continued market access are met. This involves meticulous documentation and proactive engagement with notified bodies and manufacturers.

For distributors and importers, it means verifying that their suppliers, primarily manufacturers, are adhering to the new timelines for quality management systems, notified body applications, and EUDAMED registrations. Failure to do so could lead to market access disruptions.

#Common mistakes in practice

• Misinterpreting device classification: Incorrectly classifying an IVD can lead to applying the wrong transition deadline and non-compliance with the IVDR.
• Failing to meet QMS deadlines: Not establishing an IVDR-compliant quality management system by 26 May 2025 will invalidate the extended transition period for legacy devices.
• Delaying notified body application: Manufacturers failing to submit an application to a notified body by 26 May 2025, and securing a written agreement by 26 May 2026, for relevant devices.
• Ignoring EUDAMED module declarations: Not actively monitoring the European Commission's declarations of EUDAMED module functionality, leading to missed mandatory registration deadlines.
• Assuming national derogations: Relying solely on national provisions without understanding the overarching EU requirements and specific conditions for extensions.
• Lack of due diligence on upstream economic operators: Distributors and importers failing to verify that manufacturers and authorised representatives are meeting their IVDR and EUDAMED obligations.

The IVDR and its amending Regulation (EU) 2024/1860 represent a complex framework for in vitro diagnostic medical devices. Economic operators must stay informed about the phased implementation of EUDAMED modules and the specific conditions for extended transition periods. For assistance in navigating these requirements, services like EUDAMED AI can provide structured data and compliance insights. Learn more about our services for medical device professionals.

This material is for information only and is not legal advice. For binding interpretation consult your national competent authority.