Navigating the Transition from IVDD to IVDR: Key Changes and Deadlines

The shift from the In Vitro Diagnostic Directive (IVDD) to the In Vitro Diagnostic Regulation (IVDR) represents a significant overhaul in the regulatory landscape for in vitro diagnostic medical devices within the European Union. This transition aims to enhance patient safety, ensure device efficacy, and align EU regulations with technological advancements.

Key Changes Introduced by the IVDR:

1. Risk-Based Classification System:
   The IVDR introduces a four-tier risk classification (Classes A to D), replacing the previous list-based approach. This change means that many devices previously self-certified under the IVDD now require assessment by a Notified Body .

2. Enhanced Notified Body Involvement:
   Under the IVDR, approximately 80% of IVDs will necessitate Notified Body oversight, a substantial increase from the 20% under the IVDD .

3. Comprehensive Clinical Evidence Requirements:
   Manufacturers must now provide robust clinical evidence, including performance evaluations and scientific validity data, to demonstrate device safety and effectiveness.

4. Implementation of Unique Device Identification (UDI):
   The IVDR mandates the use of UDIs to improve traceability and post-market surveillance of IVDs .

5. Mandatory Quality Management Systems (QMS):
   All manufacturers are required to establish and maintain a QMS compliant with Article 10(8) of the IVDR by 26 May 2025 .

Transitional Periods and Deadlines (as of June 2025):

To facilitate a smooth transition, the European Commission has extended the transitional periods for legacy devices, provided certain conditions are met:

• Class D Devices:

  • Application to a Notified Body by 26 May 2025

  • Formal agreement signed by 26 September 2025

  • Transition period ends on 31 December 2027

• Class C Devices:

  • Application by 26 May 2026

  • Agreement signed by 26 September 2026

  • Transition period ends on 31 December 2028

• Class B and Class A Sterile Devices:

  • Application by 26 May 2027

  • Agreement signed by 26 September 2027

  • Transition period ends on 31 December 2029

It’s important to note that these extensions apply only if:

• The device continues to comply with the IVDD and does not pose an unacceptable risk.

• No significant changes are made to the device’s design or intended purpose.

• The manufacturer has implemented an IVDR-compliant QMS by 26 May 2025 .

When preparing for compliance, manufacturers should proactively:

• Assess their device portfolios to determine the new classification under the IVDR.

• Engage with Notified Bodies early to ensure timely conformity assessments.

• Update technical documentation and gather necessary clinical evidence.

• Implement or update QMS to meet IVDR requirements.

By taking these steps, manufacturers can ensure continued market access and uphold the highest standards of patient safety.

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