MDR: What is Enovis Surgical State of the art?

The European Union Medical Device Regulation (MDR), introduced in 2021, has posed significant challenges for many medtech companies.

On top of this, Enovis International Surgical — Enovis’ division operating outside the US — has also faced the task of merging two companies during the same period.

In this article, we speak with Roberto Gabetta, Director of Regulatory Affairs for Enovis International Surgical, to discuss where the company stands in the MDR transition process and what the next steps will be.

Mr. Gabetta, it has now been four years since the MDR regulations came into effect in Europe. Could you provide an overview of the current status of our product portfolio? Where do the legacy Mathys and LimaCorporate products currently stand in terms of compliance?

Currently, most of the legacy Mathys and LimaCorporate products have either been completed or are in the final stages of transition to compliance with EU MDR (Regulation 2017/745).
 
Both companies had already initiated the necessary technical and clinical updates well ahead of the new regulation deadlines, which proved to be an invaluable advantage, and a key element that guided our strategy.

What were the main challenges you encountered in transitioning the legacy Mathys and LimaCorporate portfolios to MDR compliance?

The main challenges included updating technical documentation for legacy devices, collecting post-market clinical data for products that had been on the market for years, and managing timelines with Notified Bodies, which were often overloaded.
 
More broadly, the MDR remediation involved almost all the internal departments as well as thousands of companies around the world.
 
This required a coordinated, cross-functional effort that tested the organization’s agility and resilience, ultimately strengthening both internal collaboration and overall regulatory readiness.

Were there particular devices or product lines that presented more significant regulatory hurdles? How did you approach and overcome these challenges?

The most difficult devices to transition were those based on older technologies, and with low sales volumes, making it hard to justify investment in new clinical studies.
 
To address this, the strategy included targeted redesigns, portfolio consolidation leading to discontinuation of certain products, and increased collaboration with hospitals and arthroplasty registries to accelerate data collection. 

Since the acquisition by Enovis, have there been any notable changes in the regulatory landscape or your internal processes? What improvements or differences have you observed?

The acquisition is fostering greater harmonization of regulatory processes.
 
We are currently integrating the teams within International Surgical, enabling us to leverage a broader range of expertise.
 
As we begin working together on our first regulatory projects, the emerging synergies are highly promising.

Looking ahead, what are the next steps for Enovis International Surgical from a regulatory perspective? Can you share your vision and key priorities for the near future?

As Enovis International Surgical, we are committed to executing the mission of the Recon Regulatory Affairs team: delivering outstanding functional support that enables the global reach of Enovis products and services.
 
We aim to achieve this through empowered collaboration, distinctive expertise, dynamic and creative strategies, and thoughtful yet efficient execution — all grounded in a steadfast commitment to safety and compliance. 
 
In alignment with the company’s strategic direction, our key priorities include completing the MDR transition and expanding our portfolio in key markets through streamlined registration strategies.
 
With this framework, we are dedicated to demonstrating the full value of Enovis Surgical’s offerings in strict adherence to regional requirements, ultimately contributing to better outcomes for orthopedic patients worldwide.

What is the global situation regarding MDR, and where do other companies stand?

The global MDR landscape continues to evolve in 2025, with significant regulatory developments shaping the field.  

One of the key changes this year is the implementation of  Regulation (EU) 2024/1860, which introduces new obligations for manufacturers to report supply interruptions that could impact patient safety.  
 
Additionally, the rollout of the EUDAMED platform is progressing in stages, with core modules expected to become mandatory by mid-2026.  
 
As for where companies stand, the picture is mixed.  Larger medtech firms have mostly completed their MDR transitions and are now focused on sustaining compliance. 
 
Although the MDR officially replaced the MDD in 2021, many companies are still navigating the transition, taking advantage of extended grace periods that allow certain legacy products to remain on the market until 2027 or 2028. Small and medium-sized enterprises, in particular, continue to operate under MDD certificates, often relying on these extensions due to challenges such as limited access to Notified Bodies and the high cost of compliance.