Regulatory Affairs Regulatory Update

European Commission Proposes Extension for IVDR Compliance, Prioritizing Patient Care

Arazy Group

In a significant move to enhance patient care and transparency within the medical devices sector, the European Commission has put forth a proposal for an extension, allowing companies more time to comply with the In Vitro Diagnostic Devices (IVDR) Regulation. This regulation is particularly crucial as it pertains to tests conducted on biological samples, including vital diagnostic tools like HIV, pregnancy, and COVID-19 tests.

The proposed extension recognizes the challenges faced by manufacturers in ensuring compliance, especially for existing in vitro diagnostic devices, particularly those classified as high-risk. The proposal outlines specific conditions for an extended timeline:

  1. High Individual and Public Health Risk (Class D):

    • Products such as HIV or hepatitis tests fall under Class D.
    • These high-risk devices will have a transition period until December 2027.

  2. High Individual and/or Medium Public Health Risk (Class C):

    • This category includes products like cancer tests.
    • Devices falling under Class C will be granted a transition period until December 2028.

  3. Lower-Risk Products (Class B and Class A Sterile Products):

    • Class B includes products like pregnancy tests, while Class A covers sterile products such as blood collection tubes.
    • These lower-risk devices will benefit from a grace period extending until December 2029.

Beyond the timeline extensions, the proposal also mandates advance notice for supply interruptions, aiming to minimize disruptions in the availability of crucial diagnostic tools. Moreover, the proposal seeks to expedite the utilization of the European Medical Devices Database (EUDAMED) by the end of 2025, further enhancing transparency and accessibility of vital information.

However, it's important to note that the proposal is not finalized. It will undergo thorough review processes by the European Parliament and the Council, ensuring that it aligns with the overall healthcare objectives and regulatory landscape.

Looking ahead, a comprehensive assessment of the impact of medical device legislation is planned for 2024. This evaluation will focus on various aspects, including device availability, associated costs, and administrative burdens, with a particular emphasis on the challenges faced by small and medium-sized enterprises (SMEs) operating in the medical devices sector.

As the proposal advances through the legislative process, stakeholders in the healthcare industry will keenly watch the developments, anticipating a balance between regulatory compliance and the uninterrupted provision of essential medical services.