EU Experts Propose Reforms to Boost Stroke Care Innovation
A group of leading experts in stroke treatment, led by Dr. Bassil Akra, have proposed reforms to EU medical device regulations. They aim to present these changes to the European Commission, seeking to improve patient access to life-saving care and boost innovation.
Currently, the lengthy and costly certification process under the EU Medical Device Regulation (MDR) is hindering progress. Neurological disease and stroke, the second largest cause of death in Europe, are particularly affected. The proposed reforms include a 'fast-track' pathway for innovative technologies, similar to the FDA's Breakthrough Device Designation process. This was urged by the Croatian Meeting for Neurointerventional Development (CRONOS) conference held in Sibenik, Croatia, in May 2024.
Other reforms proposed are applying Article 82 for Early Feasibility Studies to European SMEs, and implementing a Central Oversight Agency (COA) for consistent and harmonized implementation of requirements protecting the EU Healthcare System. Many neuro-intervention technology companies, often SMEs, are forced to seek approvals in other markets due to the current regulatory landscape in Europe.
The proposed reforms, if implemented, could significantly improve patient access to life-saving stroke care and encourage innovation in the sector. They aim to simplify the approvals process, making it more accessible for SMEs and ensuring that Europe remains at the forefront of medical device technology.
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