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25BMR




Products & Services Quality, Compliance and Regulatory Regulatory Affairs

Navigating the Challenges and Costs of the New European Union Medical Device Regulation (EUMDR)

ID: POP-345


Features:

2 Info Graphics

47 Data Graphics

510+ Metrics


Pages: 60


Published: 2021


Delivery Format: Shipped


 

License Options:


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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
The new set of regulations that come with the European Union Medical Device Regulation (EUMDR) have only added to the many challenges faced by medical device companies globally. These regulations, which are four times longer than the previous ones, have resulted in increased costs and complexity of doing business across the EU.

Best Practices, LLC undertook this benchmark study to probe the real-world costs and challenges that companies are experiencing during this transition from MDD/AIMD to MDR - and some of the effective ways in which they are responding to these challenges. This report provides segmented perspectives on product class types and company size.

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


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

Study Snapshot

Best Practices, LLC engaged executives from 25 medical device companies across 15 therapeutic areas. More than ninety percent of the respondents served at a director or VP level or above.

Key topics covered in this report include:

  • Cost analysis for EUMDR program implementation
  • Influence of regulatory class and company size on implementation and maintenance costs for EUMDR
  • Impact of EU business operations revenue on implementation cost
  • Product risk and therapeutic area influence on cost
  • EUMDR spend breakdown across different compliance activities

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • Product & Condition Risk: Product type and therapeutic-area risk independently and in combination influence post marketing costs at nearly companies.
  • Implementation Cost: Mid-size companies report higher implementation costs. This may reflect regulatory complexity in growth portfolios.

Table of Contents

Sr. No.
Topic
Slide No.
I.
Key Findings and InsightsPg. 3
II.
Overview & Hypotheses to ExplorePg. 5
III.
EUMDR Implementation Costs AnalysisPg. 12
IV.
Regulatory Class + Company Size InfluencePg. 23
V.
EU Revenue Influence on CostPg. 35
VI.
Product Risk, TA / Condition Influence on CostPg. 44
VII.
Activities & Cost Drivers Drill Down AnalysisPg. 48
VIII.
Participant DemographicsPg. 54