Navigating the Challenges and Costs of the new European Union Medical Device Regulation (EUMDR): Implementation and Product Class Costs

STUDY OVERVIEW

The European Union Medical Device Regulation (EUMDR) is challenging medical device companies globally.

EUMDR creates new regulatory expectations. These changes result in increased costs and complexity of doing business in the EU. This benchmark study probes the real-world costs and challenges that companies are experiencing during this transition from Medical Device Directive(MDD)/Active Implantable Medical Devices to new requirements in Medical Device Reporting (MDR). The MDR is four times longer than MDD requirements.

This study examines the costs associated with implementation of the new requirements and how those costs are reflected across medical device product classes.

This study provides segment perspectives on product class types (i.e. Class I, II and III) and company size.


KEY TOPICS

• Study Overview
• EUMDR Implementation Costs Analysis
• Regulatory Class + Company Size Influence 
  

• What percentage of your EU products are assigned to the following classifications?
• Anticipated total EUMDR implementation costs as a percentage of EU sales during EUMDR transition?
• Do you have an active implementation program to meet the EUMDR requirements?
• What is your estimated spend increase to sustain the products on the market post-EUMDR transition?
  

• Product Class: EUMDR will generate cost increases across all product classes. Class II & III expect greater implementation cost increases.

Best Practices, LLC engaged executives from 25 Medical Device and technology companies across 15 therapeutic areas.

Industries Profiled:
Medical Device; Technology; Pharmaceutical; Health Care; Science; Manufacturing; Research; Diagnostic


Companies Profiled:
Becton Dickinson; RaySearch Laboratories; Medtronic; Zap; Teleflex; SinuSys; Cardinal Health; Atos; Boston Scientific; Rhythmlink; Thermo Fisher; Celo Nova; ConMed Corporation; Kestra; Zimmer Biomet; Xodus Medical; 3M Company; Establishment Labs; inStem; Aqualizer; Avanos Medical; Ascensia; Needle Tech Products; Dentsply Sirona; Foundation Medicine

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