Beatriz Dominguez Gonzalez May 25, 2021


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?

To help you get to grips with the new MDR, we’ve put together a brief overview of the new regulation for Point-of-Care 3D Printing facilities. See it in full below or download it as a PDF.

Johan Hermans, EMEA Associate Director for Personalized Solutions, Zimmer Biomet


Interested in learning how to integrate a QMS into your workflow?

The Materialise QMS training can help.

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