The new regulations include a series of extremely important improvements to modernize the current system.
These include:
- stricter criteria for the designation and supervision of notified bodies
- a new risk classification system for in vitro diagnostics
- more transparency through the creation of an extensive EU database on medical devices and a traceability system based on unique product identification
- stricter requirements for clinical evidence
- more detailed requirements for manufacturers on post-market monitoring
- better coordination mechanisms between EU countries in the field of vigilance and market surveillance
Knowing more? Look here 👉🏻 https://www.gbo.com/nl-nl/bedrijf/whats-new-in-the-mdr-and-ivdr
For us, health is the highest personal priority.
This inspires our daily mission to provide life sciences and healthcare professionals with advanced and sustainable products and solutions. It is the passion and dedication of our people that make the difference. That is why our team of experts is working hard and passionately to implement the new regulations.
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