EU: Parliament Votes to Revise MDR and IVDR
On 23 October, the European Parliament has adopted a resolution to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) to address ongoing implementation challenges and support patient access to essential medical devices by 2025.
Key elements of the resolution include:
- Reducing Certification Bottlenecks: Streamlining certification processes and improving timelines and costs to ensure ongoing availability of critical medical devices and diagnostics.
- Support for Innovation: Establishing an accelerated regulatory pathway for breakthrough and innovative medical technologies, particularly for orphan, pediatric, and other devices addressing unmet medical needs.
- Enhanced tranparency and consistency across notofied bodies: Standardising assessment timelines, reducing administrative burdens, and improving consistency across notified bodies to aid manufacturers and increase market access predictability.
- Support for SMEs: Prioritizing policies that help small and medium-sized enterprises (SMEs) navigate the regulatory landscape with fewer administrative challenges.
- Improved Governance: Proposing a single governance structure to oversee the regulatory system, aiming for efficiency, sustainability, and improved patient outcomes.
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