Saturday, March 2, 2024

European Proposal for Diagnostic Medical Devices to Extend Compliance Timeline

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The European Commission (EC) has introduced a proposal aimed at extending the compliance timelines for legacy In Vitro Diagnostic Medical Devices (IVDs) under the In Vitro Diagnostic Medical Devices Regulation (IVDR). Additionally, the proposal includes plans to expedite the rollout of EUDAMED, the European Databank on Medical Devices.

The EC’s press release emphasizes that this proposal is designed to ensure the availability of In Vitro Diagnostic Medical Devices and enhance transparency in the field of medical devices. It addresses the challenges faced by manufacturers and regulatory bodies in complying with the IVDR and implementing EUDAMED.

Extended Compliance Deadlines Proposed for Legacy Diagnostic Medical Devices

Extended IVDR Compliance Timeframes for Legacy In Vitro Diagnostic Medical Devices: Legacy IVDs, which were already on the EU market before the IVDR’s Date of Application (May 26, 2022), will have extended compliance deadlines under the proposed changes. The transition timeframes for different classes of legacy IVDs are as follows:

  1. Legacy IVDs Class D (IVDR) must achieve compliance by December 2027.
  2. Legacy IVDs Class C (IVDR) must achieve compliance by December 2028.
  3. Legacy IVDs Class B and Class A sterile (IVDR) must achieve compliance by December 2029.

Accelerated Implementation of EUDAMED: The proposal also includes plans to expedite the implementation of EUDAMED modules as soon as they have been audited and declared functional. This approach is expected to result in several EUDAMED modules becoming operational by the end of 2025.

In Vitro Diagnostic Medical Devices

European Legislative Process Begins for Proposal on Medical Device Compliance Timelines

The proposal will now undergo the standard European legislative process, which involves review and approval by the European Parliament and Council for adoption. These bodies will assess the proposal’s implications and determine whether it aligns with the objectives of ensuring the safety and availability of medical devices in the EU.

The extension of compliance timelines for legacy IVDs and the accelerated rollout of EUDAMED are measures that are likely to be welcomed by industry stakeholders. The IVDR compliance process has faced challenges, and the use of EUDAMED is considered crucial for ensuring access to medical device data in the European market. Further analysis of the EC’s proposal will be provided by Emergo by UL shortly, offering deeper insights into its potential impact on the medical device industry.


Resource: Emergobyul, January 23, 2024

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