EU Launches Major Consultation to Simplify Medical Device Regulations
The European Commission has launched a comprehensive consultation process to revise the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). This wide-ranging engagement involves diverse stakeholders, aiming to simplify regulations while maintaining safety standards. The Commission anticipates positive economic impacts and supports for innovation across the EU.
The consultation, which began earlier this year, includes public online discussions, stakeholder dialogues, expert tables like CASE4Med, and events such as symposiums and innovation forums. It involves politics, industry, healthcare providers, patient groups, scientific networks, and regulatory bodies. The Commission has set an indicative timeline for the fourth quarter of this year to adopt the revision proposal.
The call for evidence highlights challenges like unpredictable certification timelines, inconsistent practices, and regulatory requirements exceeding device risk profiles. The industry has pressed for reform due to market access barriers and administrative burdens. The revision aims to simplify the regulatory framework while preserving patient safety. MedTech Europe has provided detailed feedback, outlining priorities for the process. The Commission seeks to reduce administrative burden, enhance certification process predictability, and make conformity assessment requirements more proportionate.
The European Commission's initiative to streamline MDR and IVDR requirements is underway, with a focus on reducing burden, enhancing predictability, and proportionate assessment. The revision is expected to promote efficiency, innovation, and sound governance, with the proposal set for adoption later this year.
