Apply Lessons from EU MDR to Upcoming Regulatory Changes

Deadlines for complying with the European Union’s Medical Device Regulation (EU MDR) have been set, staggered, extended, and passed. At press time, the European Commission is considering whether to clarify guidelines, change regulations, and potentially extend milestones again. It’s a testament to how complicated and difficult the compliance and remediation effort is. 

Adding to the challenge, most medical device companies struggle to execute large remediation programs.  

• Historically such programs have been one-time efforts, so there are rarely standard operating procedures, allocated budgets, or explicit ownership. 
• Fixing compliance is an added expense, and the return on investment is difficult to calculate.  
• Remediation programs are complex, requiring alignment across multiple functions and business units.  
• And the usual incentives may be misaligned as organizations typically reward product innovation and sales growth, and remediation may disrupt both.  

However, maintaining compliance, on-market surveillance, and reporting will last through a product’s lifecycle, so it’s not a single effort. And the pace of other major remediation challenges, such as eliminating per- and polyfluoroalkyl substances (PFAS) and reducing ethylene oxide (EtO) emissions, is accelerating. Compliance is no longer just an initial development cost. It’s an ongoing strategic investment in the future. To remain competitive, medical device companies need to get better at remediation. 

Integrated Project Management Company, Inc. (IPM) has led medical device companies through EU MDR remediation and compliance programs. But the remediation work doesn’t end with product filing. As the programs have matured, IPM consultants are now helping industry leaders respond to notified body inquiries, standardize on-market surveillance, and address upcoming remediation needs beyond EU MDR.  

Download the complete article to learn from our experience how to complete MDR compliance while preparing your organization for future global regulation changes. 

You’ll be better equipped to: 

• Understand the needs and demands of the remediation program. 
• Align compliance programs with and against strategic priorities. 
• Provide structure and governance, and enable cross-functional collaboration.  
• Build and maintain buy-in with executives and stakeholders like notified bodies and regulatory agencies.