?? Urgent Call to Revise the Medical Devices Regulation! ??

The European Parliament has recognized the pressing need to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to ensure the safety and accessibility of essential medical devices across the EU.

?? Key Highlights: Access Disparities:

• Significant disparities in access to medical devices persist, impacting patient care and health equity.
• Regulatory Challenges: While the MDR and IVDR aim to enhance safety and transparency, many stakeholders, especially SMEs, face challenges navigating complex regulations, leading to delays and shortages.
• Need for Innovation: The regulatory frameworks must better accommodate innovative technologies, especially in areas of unmet medical need.

?? The Parliament urges the Commission to:

• Propose necessary revisions by Q1 2025.
• Streamline regulatory processes to improve transparency and reduce administrative burdens.
• Ensure timely market access to life-saving devices, prioritizing innovative solutions.

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