Stroke Experts Propose EU MDR Reforms for Faster Access to Novel Devices
A group of leading stroke treatment experts, gathered at the Croatian Meeting for Neurointerventional Development (CRONOS), has proposed significant reforms to EU medical device regulations. The reforms aim to improve accessibility to novel devices for treating stroke and other neurological diseases, currently hindered by the EU Medical Device Regulation (MDR). The proposed changes will be presented to the European Commissioner for Justice.
The proposed reforms include a 'fast-track' pathway for innovative technologies, mirroring the US FDA's breakthrough device designation process. This pathway incorporates a pre-submission review process and conditional approval based on data from just 20% of patients in clinical trials. Other suggested changes involve applying Article 82 for Early Feasibility Studies to European SMEs, introducing Key Performance Indicators (KPIs) for notified bodies, and establishing a Central Oversight Agency (COA).
The CRONOS conference, attended by leading clinicians, innovators, and industry partners from Europe and beyond, discussed the challenges and strategies for overcoming the MDR's inhibition of innovation. The current MDR is preventing access to life-saving stroke care and may delay the availability of novel technologies to patients in the European countries.
The CRONOS panel's proposed reforms seek to streamline the regulatory process, enabling quicker access to innovative stroke treatment devices. The group's recommendations will be presented to the European Commissioner for Justice, aiming to improve EU medical device regulations and ultimately enhance patient care in the European countries.
