A Top-Level Analysis of Europe’s MDR
iData’s analysts work extensively to collect data and insight from a variety of resources to create both syndicated and custom research reports for their successful clients world-wide. Owing to their in-depth understanding of the markets and first-hand experience with the appropriate data, our analysts have looked into the effects of the Medical Device Regulation (MDR) with regard to the population trends in Europe. With this analysis on the current quarrel facing the orthopedic trauma market, we hope to provide insight for our clients as to why this policy change should matter for strategic decision-making.
The orthopedic trauma market in Europe, consisting of devices used for the fixation of extremity fractures, has seen a negative growth trajectory and is predicted to maintain this rate for the next few years. In contradiction, unit sales are forecasted to grow due to the increasing number of procedures necessary for Europe’s aging population. Why are we lacking correlation to the population causation? Due to price pressure and tender competition resulting in a market value decrease from the aftermath of the new Medical Device Regulation by the European Union (EU).
What is the New Medical Device Regulation?
The new Medical Device Regulation is a set of mandates that govern the production and distribution of medical devices in Europe. All medical device companies must be compliant with the regulation if they want to sell their products in the European marketplace. Compared to its predecessor, the MDD (Medical Device Directive), the MDR contains regulation on software as a medical device (SaMD) and Active Implantable Medical Devices (AIMD) as well as updated demographic insights.
When Will the MDR be Put into Place?
The MDR was approved by the European Union in April 2017 and received a planned date of application for May 26th 2020; however, the effects of the COVID-19 pandemic convinced the European Parliament to come to a vote in April 2020 and postpone the MDR by one year. As of May 25th, 2021, the MDR was put into effect.
How Will the MDR Affect the Orthopedic Trauma Market?
It must be said that MDR is less focused on the pre-approval stage of medical device manufacturing, and rather promotes a cyclical approach to medical device regulation. This increased set of regulations follows the concern for Europe’s aging population of 12.4 million people, and as the population continues to age, this demographic faces a significantly greater need for quality-controlled medical devices. Consequently, the increase in regulations will most likely slow orthopedic trauma device innovation therefore decreasing the overall market value.
In the short term, the Medical Device Regulation will negatively impact the European orthopedic trauma market and its overall market value. Niche devices are likely to be eradicated due to higher costs associated with new regulations; however, the main driver of the market, the aging population, will not be affected by MDR as previously predicted. Instead, newer, more costly devices and materials will be given precedence in cases where they benefit the aging population on quality control. The pitfall we predict will be the cost of devices which will likely prevent a shift towards innovation in the foreseeable future. For more information on the European Orthopedic Trauma market, including unit sales, average selling prices, market drivers and limiters, competitive market share analysis, and more, follow the link below to receive a free research summary of this report.