pfmmedical leads the way with MDR compliance


Many companies are facing major challenges in having to comply with the new requirements of the EU Medical Device Regulation, or MDR. But pfm medical ag, a medium-sized, family-owned company based in Germany which operates internationally and has been delivering special solutions in the healthcare sector for 50 years, saw the importance of taking prompt action to adapt to these changes right from the outset. pfmmedical is a medical technology company offering products, services and therapy solutions in four main medical fields: surgery, histotechnology, cardiovascular technologies and infusion.

“We prepared early on, taking steps to ensure our staff could cope with the added workload, and then we got the processes up and running,” reminisces Christof Schmeer, Vice President Quality & Regulatory Affairs. This forward-looking action has paid off. By now pfmmedical has obtained its first certifications, and all other processes still under way are comfortably on schedule. The company has obtained MDR certifications for Class Ir, Class IIa and Class III devices, and applications have already been submitted to DEKRA for two more products. “We are confident that with our products we will be able to successfully implement MDR compliance within the specified timeframe,” continues Schmeer. Given the current situation in the world market, this sends an important signal to customers. Schmeer emphasises the salient point: “At present we don’t see any risk of disruption to the supply of our products due to not being able to complete the required steps within the specified timeframe.”

In the complex process surrounding MDR compliance, pfmmedical also has the particular advantage that it collects data from clinical studies. Not for nothing does the company espouse the vision: “Leading evidence-based medicine.” This means that pfmmedical is able to draw on an extensive, well-founded body of study data. This is a clear advantage when it comes to the MDR process. 

And there’s also another bonus to mention here. pfmmedical has bundled its extensive knowledge and experience of all things MDR into an independent subsidiary called pfm medical expert gmbh. pfmmedical expert has been responsible for implementing the MDR process at pfmmedical. It also provides support and consulting services to external companies in the healthcare sector, offering a very extensive portfolio of services relating to MDR compliance.