MedTech Europe welcomes the Medical Device Regulation’s entry into full application and urges continued work to deploy the new regulatory system
Posted on 02.06.2021
The 26 May 2021, date of application of the Medical Device Regulation (MDR), marks an important milestone for the medical devices sector. Since the MDR’s inception more than a decade ago, the medical technology industry has fully supported its goals and has heavily invested resources to comply with its strengthened requirements, geared towards protecting patients even further and increasing trust in the EU’s legal framework.
The new regulatory regime for medical devices provides additional benefits including a strengthened Notified Body system, a new database enabling more transparency, a unique device identification system facilitating supply chain traceability, stricter clinical evidence requirements and more.
“Medical technologies save lives, improve health and contribute to sustainable healthcare. The new Regulations are welcomed by our industry as these will strengthen patient safety and the existing robust approval system of our sector”, says Serge Bernasconi, CEO of MedTech Europe.
While the first “implementation” chapter closes, the medical devices industry and other stakeholders are now entering a second major chapter of the MDR story. While some positive progress has been achieved in preparing the new infrastructure over the past four years, some key pillars of that infrastructure are still not fully operational or even in place.
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