What Is the EU MDR?
In May 2017, the EU published the new European Union Medical Device Regulation (EU MDR). The new regulation replaces the MDD (Medical Device Directive) and went into force on May 25, 2017. Medical devices have three years to comply while in vitro diagnostics have five years. The reasons for the new regulation are admirable. As stated, “This Regulation aims to ensure the smooth functioning of the internal market…[it] sets high standards of quality and safety for medical devices in order to meet common safety concerns…” Essentially, the EU wants to ensure that medical devices are safe, high quality, meet stated expectations, and improve patient health. The EU also wants to take advantage of the technological and scientific progress made over the last 20 years.
Better Devices, but There’s Work to Do
While taking advantage of technology advancements will lead to greater efficiencies for medical device companies, becoming compliant will require work. The EU MDR wiki states, “The new EU Medical Device Regulation (EU MDR) is not radically different from the current Medical Device Directive (MDD). That’s not to underestimate the amount of work that will be required to switch from the current MDD to the new EU MDR.”1 The new regulation is largely an extension of the existing regulation, but it requires far more data. In many ways, the new regulations require processes that medical device companies should be following anyway, but have been a challenge to implement, especially without the right technology.
Considering that every medical device company that wants to do business in Europe will be undergoing efforts to comply, this transition period represents an excellent opportunity to restructure processes in ways that are more efficient, but will also lead to more innovative and higher quality devices. The transition may be challenging, but those who are most successful will likely enjoy a competitive advantage. While the scope of the new regulation is quite broad, its implications are especially significant for product teams who will – either directly or behind the scenes – participate in the product submissions process. This eBook shares advice to prepare product data for regulatory submissions through a programmatic and extensible approach. In this view, EU-MDR compliance serves as a catalyst for implementing sound product design, change and configuration control best practices across your product development lifecycle.