Navigating the Challenges and Costs of the New EUMDR

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 Insights	Pg. 3
II.	Overview & Hypotheses to Explore	Pg. 5
III.	EUMDR Implementation Costs Analysis	Pg. 12
IV.	Regulatory Class + Company Size Influence	Pg. 23
V.	EU Revenue Influence on Cost	Pg. 35
VI.	Product Risk, TA / Condition Influence on Cost	Pg. 44
VII.	Activities & Cost Drivers Drill Down Analysis	Pg. 48
VIII.	Participant Demographics	Pg. 54

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

ID: POP-345

Features:

Pages: 60

Published: 2021

Delivery Format: Shipped

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