A cost-effective approach to EU MDR compliance

PA Consulting medtech expert Hilde Viroux and PA life sciences expert Maggie Chan co-authored a series on EU MDR Compliance for Med Device Online with Dona O’Neil from Northeastern University. Click here to read their second article on how medical device manufacturers can comply with EU MDR activities in cost-effective ways.

In our previous article, “Navigating EU MDR Compliance: Overcoming Challenges To Sustain Your Certification,” we discussed the challenges a medical device manufacturer faces once EU MDR certification has been obtained. In this article, we will focus on being cost-effective in the face of the cost of compliance as it pertains to maintaining EU MDR activities.

The Current Economic Climate

The current economic climate is characterized by a broad-based and sharper-than-expected slowdown, with inflation higher than seen in several decades. The cost-of-living crisis, tightening financial conditions in most regions, Russia’s invasion of Ukraine, and the lingering COVID-19 pandemic all weigh heavily on the outlook.

According to the latest data, the U.S. economy grew by 3.3% in the fourth quarter of 2023, driven by consumer spending and exports, but faced headwinds from rising wages and imports. The EU and the Eurozone economies stagnated in the same period, as weak domestic demand and supply disruptions offset the recovery in external trade.

Click here to read the full Med Device Online article