Medical Design and Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe

Report slams European Union’s high-risk medical device approvals rate

January 2, 2018 By Heather Thompson

European Union medtech regulationsA health economics and outcomes research group has concluded that the assessment for high-risk medical devices in the European Union is of low quality and needs improvement. The report appears in the December 2017 issue of Value in Health by ISPOR.

The authors looked at 1,376 health technology assessment (HTA) reports filed between 2010 and 2015. Of those reports, 93 were eligible for analysis. Researchers rated several criteria, including:

  • Evidence base — whether the evidence in the HTA reports was primarily based on submissions by the manufacturer, on data identified through an independent systematic literature search, or both.
  • Type of evidence — distinguished between “direct” (e.g., head-to-head trials) and “indirect” evidence. Direct evidence from a well-conducted randomized controlled trial or a meta-analysis of such evidence was seen as providing the most valid estimates regarding the effectiveness of competing health care interventions. However, in some cases, interventions were not directly compared in RCTs. If there was insufficient evidence from direct-comparison trials, results of trials with different comparisons can be used to estimate the effects of treatments.
  • Level of evidence — Using Cochrane Collaboration level of evidence analysis, researchers classified clinical studies used in HTA reports.
  • Further considerations of scientific evidence — Whenever possible, the researchers behind hte report collected the total number of considered studies per HTA report. If HTA reports explicitly evaluated study quality (i.e., the risk of bias) using a specific tool or approach, the information was also considered for analysis.

In more than half the reports identified, evidence for the demonstration of the effectiveness and safety came from clinical studies of a moderate or low level of evidence, mainly case series or reports. Additionally, the findings illustrate that even if systematic reviews and randomized controlled trials were available for assessment, most of these studies showed an unclear or high risk of bias according to the specific tools used in their reports. The study showed that the evidence used in HTAs is systematically low for high-risk devices and the authors called for stricter quality requirements in trial designs and more alternative evidence sources to achieve marketing authorization.

The findings should be of concern for medical device companies that market to European countries. Authors also noted the HTA agencies in the EU face tremendous hurdles in making recommendations to healthcare decision makes. Although medical device investigations must adhere to principles of good clinical practice, there is no legal requirement for valid demonstration of the clinical benefit of a device in order for it to be in compliance with applicable directives. As a consequence, many high-risk devices are granted licensure based on low-quality evidence.

Although the evidence gap is a well-known problem, this is the first attempt to document the issue, according to report author Britta Olberg,MScPH, of the Berlin University of Technology in Germany.

“Our results show that additional changes are necessary, specifically with regard to the marketing authorization process of medical devices, with stricter quality requirements based on methodologically robust trials, possibly in combination with other evidence sources,” Olberg said.

Olberg strongly recommended enforcing a requirement of high-quality studies for demonstrating the clinical efficacy and safety of high-risk medical devices.

Comments

  1. Corey Jaseph says

    January 3, 2018 at 10:16 pm

    Europe is going to improve their regulatory processes right off the market. They have already created a clinical burden for even low risk devices that is MUCH higher than FDAs.

Related Articles Read More >

A photo of the probiotic-powered dissolvable batteries.
Probiotics-powered bioresorbable battery can run more than 100 minutes, researchers say
How this device broke through the blood-brain barrier
A photo of TekniPlex Healthcare,s new facility in Madison, Wisconsin.
TekniPlex Healthcare opens new barrier protection systems facility
Nelson Labs plans to double cleanroom capacity
“mdo
EXPAND YOUR KNOWLEDGE AND STAY CONNECTED
Get the latest medical device business news, application and technology trends.

DeviceTalks Weekly

See More >

MDO Digital Edition

Digital Edition

Subscribe to Medical Design & Outsourcing. Bookmark, share and interact with the leading medical design engineering magazine today.

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
DeviceTalks

DeviceTalks is a conversation among medical technology leaders. It's events, podcasts, webinars and one-on-one exchanges of ideas & insights.

DeviceTalks

New MedTech Resource

Medical Tubing

MassDevice

Mass Device

The Medical Device Business Journal. MassDevice is the leading medical device news business journal telling the stories of the devices that save lives.

Visit Website
MDO ad
Medical Design and Outsourcing
  • MassDevice
  • DeviceTalks
  • MedTech100 Index
  • Medical Tubing + Extrusion
  • Medical Design Sourcing
  • Drug Delivery Business News
  • Drug Discovery & Development
  • Pharmaceutical Processing World
  • R&D World
  • About Us/Contact
  • Advertise With Us
  • Subscribe to Print Magazine
  • Subscribe to our E-Newsletter
  • Listen to our Weekly Podcasts
  • Join our DeviceTalks Tuesdays Discussion

Copyright © 2025 WTWH Media, LLC. All Rights Reserved. The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media LLC. Site Map | Privacy Policy | RSS

Search Medical Design & Outsourcing

  • Home
  • Medical Device Business
    • Mergers & Acquisitions
    • Financial
    • Regulatory
  • Applications
    • Cardiovascular
    • Devices
    • Imaging
    • Implantables
    • Medical Equipment
    • Orthopedic
    • Surgical
  • Technologies
    • Supplies and Components Index
    • Contract Manufacturing
    • Components
    • Electronics
    • Extrusions
    • Materials
    • Motion Control
    • Prototyping
    • Pumps
    • Tubing
  • MedTech Resources
    • Medtech Events in 2025
    • The 2024 Medtech Big 100
    • Medical Device Handbook
    • MedTech 100 Index
    • Subscribe to Print Magazine
    • DeviceTalks
    • Digital Editions
    • eBooks
    • Manufacturer Search
    • Podcasts
    • Print Subscription
    • Webinars / Digital Events
    • Whitepapers
    • Voices
    • Video
  • 2025 Leadership
    • 2024 Winners
    • 2023 Winners
    • 2022 Winners
    • 2021 Winners
  • Women in Medtech
  • Advertise
  • Subscribe