The medical device sector plays a key role in protecting public health, contributing significantly to improving quality of life through innovative solutions for diagnosis, prevention, treatment, and rehabilitation.
With the entry into force of Regulation (EU) 2017/745, MDR (Medical Device Regulation), the European Union has taken a decisive step forward to strengthen patient safety and the reliability of medical devices, raising quality standards and harmonising rules across the internal market.
Stricter Requirements for Safety and Performance
While the core principles of the MDR remain consistent with previous directives, the regulation introduces more stringent requirements to ensure the safety and performance of devices throughout their entire lifecycle.
Key changes include:
• ongoing and proactive post-market monitoring, supported by stronger vigilance and market surveillance systems;
• enhanced traceability through the Unique Device Identifier (UDI), enabling complete product tracking from manufacturing to end use;
• higher quality and reliability for all medical devices placed on the European market.
“The MDR also places great emphasis on transparency and the accountability of economic operators,” explains Manuela Capelli, Quality Assurance & Regulatory Affairs at Biopsybell. “Manufacturers, importers, and distributors are now required to take a more proactive role, with stricter control and documentation obligations and full traceability along the supply chain. Product information has also become more accessible through official channels, such as corporate websites, packaging, and labels, and through the new European database EUDAMED, which ensures transparency and accountability across the entire sector.”
A Concrete Impact for Patients and Operators
For patients and users alike, these improvements translate into safer and higher-performing devices, with features and instructions that are presented more clearly and in greater detail.
In this way, the MDR strengthens the European Union’s role as a guardian of public health and patient safety, while fostering a culture of responsible and sustainable innovation within the medical device industry.
