Regulation (EU) 2017/745: A New Quality and Safety Standard 

Regulation (EU) 2017/745 (MDR) has raised the quality and safety requirements compared to the former Directive 93/42/EEC (MDD). While the MDD focused on basic safety requirements, the MDR introduces stricter measures to ensure patient protection. This new standard requires more rigorous clinical evaluation, product traceability and more effective post-market surveillance. 

The main objective of the MDR is to ensure that all medical devices on the European market meet an optimal level of safety and functionality. This translates into increased requirements for manufacturers, including more comprehensive clinical testing and the need for detailed technical documentation. 

Since 2015, Bexen Medical has worked tirelessly to adapt to these new regulations. This effort has involved a complete overhaul of our internal processes, ensuring that every product meets the highest standards of safety and efficacy. Our commitment to quality has been a constant, and the MDR certification is testament to this effort. 

“The most complex thing has been to dimension ourselves in terms of capacity and knowledge, considering at all times the ups and downs of the sector, which have been many and complex. However, we have maintained our constant course and an intense level of activity at all times, without this interfering with the daily needs of the company,” says Gorka Ramirez, our Technical Director. 

Bexen Medical, among the first companies at national level to obtain the MDR 

The improvements introduced by the MDR not only benefit patients, but have also allowed Bexen Medical to innovate and develop new solutions. We are now better positioned to incorporate innovative products into our portfolio, confident that they meet the highest standards of safety and quality. 

In short, the transition to MDR represents a significant step forward for the medical device industry and a renewed commitment by Bexen Medical to excellence and patient safety. 

Date of publication: 08/01/2024

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