8 New Rules of the Medical Device Regulation for Point-of-Care Facilities
As of May 26, 2021, the new Medical Device Regulation (MDR) will be fully applicable. But what does that mean for your hospital, and what rules do you need to follow? We’ve put together a brief overview of the eight key rules in article 5.5 that you need to know.
The most notable change brought about by these new rules is that health institutions will need a quality management system (QMS) in their 3D printing labs. A detailed QMS provides a structured framework that can help hospitals optimize the quality of patient care, reduce mistakes in the production process, and increase the credibility of Point-of-Care 3D Printing labs.
With vast experience as a device manufacturer meeting all necessary requirements while operating within a regulated QMS, it’s one area that Materialise is very familiar with. But what about the other MDR requirements?
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