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The MDR: A Sign of Success

Posted in News on 27th February 2018

An Anecto opinion piece.

If you’re a medical device manufacturer, the persistent elephant in your room is probably regulation. This issue is best currently represented by the EU medical device regulations (MDR), which replaced the medical device directive (MDD) when published in May 2017, and is currently in a transition period.

In 2020, the MDR will be legally binding (2022 for the IVDR). These are short windows for product developers who are surely feeling the pinch to align their processes and technical files with newly burdensome expectations. So, it is easy to view the MDR and similar regulations as a giant hindrance to innovation.

MDR, Medical Device Directive, EU MDR, IVDR,

As a test laboratory that supports medical device manufacturers, the health of the medtech industry is just as important to Anecto as the customers we serve. That is why we feel there is another way to view the MDR: as a giant symbol of success.

Every medical device recall creates a major ripple effect of negative attention. What the MDR and similar regulations do is recognize the vast accomplishments made in medical technology along with the promise of more to come. The more lives saved by medical technology, the tougher the rules will get.

By most estimates, the global market for medical devices is approaching $400 billion annually. Make no mistake about it, medtech is neither an exercise in futurism nor is it a passing fad; medtech has arrived and it is here to stay. The take away is that this is a serious and mature industry with hefty expectations, by doctors and patients as well as government regulators.

EU MDD, EU MDR, Medical Device Regulation, IVDR, In-Vitro Device Regulation, CE marking, Notified bodies, Clinical investigation, approval, definitions, medical devices

The European Parliament building

This business is certainly not for amateurs either, and everyone who is a part of it should recognize that participating in such an inventive field comes with major responsibility. That responsibility is supplying the global demand for life-saving medical technology through the development of medical products that are reliably safe to use.

From our own interactions with product manufacturers, we know that they’re up to the challenge, and we’re here to support them every step of the way.

The MDR is something we’ll be playing close attention to as the transition period winds down, and we expect medtech to be better off because of this persistent focus on product safety.