Navigating the Challenges and Costs of the new European Union Medical Device Regulation (EUMDR): Cost Impact by Company EU Revenue Level, TA/Condition and Implementation Activities

STUDY OVERVIEW

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

EUMDR creates new regulatory expectations with the device reporting regs four times longer than previously. 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). 

This study examines the cost impact the new regs will have on companies with large vs. small EU revenues and on the product's therapeutic area/condition. The study also looks at costs across implementation activities.

This study provides segment perspectives based on company's EU revenues, company size and product risk.


KEY TOPICS

• Study Overview
• EU Revenue Influence on Cost
• Product Risk, TA / Condition Influence on Cost
• Activities & Cost Drivers Drill Down Analysis

• Implementation cost for initial EUMDR compliance, by company revenue
• What is estimated spend increase to sustain products post-EUMDR transition?
• Implementation cost for initial EUMDR compliance, as percentage of EU sales
• What is estimated spend increase to sustain products post-EUMDR transition, by company EU revenue
• Do different product and risk factors affect post-marketing EUMDR spend?
• Of total program cost to become EUMDR complaint, what is percentage breakdown of spend across the following activities?
• Of total program cost to become EUMDR complaint, what is percentage breakdown of spend, by company size?
• Of total program cost to become EUMDR complaint, what is percentage breakdown of spend, by product classification?
  
  

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

• EU Revenue: EUMDR implementation costs nearly double as EU revenue increases relative to total sales.

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

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.