Nerac

Information That Drives Innovation

We’re here to help with your research needs
+1 860 872 7000
Customer Access
  • Home
  • What We Do
    • Innovation Insights and Consulting Practice
    • Regulatory
    • Medical Device and Life Sciences
    • Technology Scouting and Innovation
    • Market Research
    • Intellectual Property
    • Commercialization Services for TTOs and Start-Ups
    • Critical Updates
  • Who We Serve
  • How to Engage
  • Why Nerac?
  • Meet our Team
    • Leadership Team
    • Our Analysts
    • Our Partners
  • Nerac Insights and Publications
    • Articles
    • Case Studies
    • Press Room
    • Videos
    • Webcasts
    • White Papers
  • Contact Us
You are here: Home / Nerac Insights / Articles / The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements

The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements

Facebook0
Google+0
LinkedIn0
Twitter0

By Donna Mitchell-Magaldi, Nerac Analyst,

On March 20, 2010, the revised Guideline; MedDev 2.7.1 Rev 3 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies became a requirement for obtaining and maintaining a CE Mark for all classes of devices marketed in the European Union. An important component of the MedDev 2.7.1 Rev 3 is the evaluation of the clinical literature (European Commission, 2009). The literature search is used to identify clinical data that is outside the manufacturer’s possession and can be used to assist in the evaluation of the device in question. The literature can address the specific product or an equivalent device (MedDev 2.7.1 Rev 3).

 

Read The Full Article Here!

Related Posts

  • The Costs of Regulatory Noncompliance in the Medical Device Industry: Is it Worth the Gamble?
    83
    By Donna Mitchell-Magaldi, Nerac Analyst, The global medical device market was valued at $350 billion dollars in 2012 (Mddonline.com, 2012).  The US market was valued at $127 Billion dollars in 2013 making it the largest medical device market in the world (Prweb.com, 2013).  However, millions of dollars are lost every year due to regulatory noncompliance issues…
    Tags: device, medical, read, donna, analyst, nerac, mitchell-magaldi, article, full
  • Are Your Devices State-of-the-Art?
    81
    By Ron Sills, Nerac Analyst Originally Published: September 29th, 2014 The European Union’s Council Directive  93/42/EEC concerning medical devices  contains the essential requirements to be met by medical device manufacturers in order to market their products in the 28 member countries.  A technical file for Class IIa and IIb devices, or a design dossier for…
    Tags: devices, medical, requirements, device, manufacturers, read, analyst, nerac, european, union
  • Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond
    79
    By Ron Sills, Nerac Analyst, and Donna Mitchell-Magaldi, Nerac Analyst Originally Published: September 26th, 2014 In 2009, the European Commission released MedDev 2.7.1 Rev.3 “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” as a supplement to the requirements of the EU Medical Device Directive 93/42/EEC.  In order for medical devices to be marketed in…
    Tags: medical, clinical, literature, device, ce, notified, nerac, manufacturers, mark, european
  • Case Studies
  • White Papers
  • Webcasts
  • Articles
    • Nerac Strategist
    • Energy
    • Food & Nutrition
    • Intellectual Property
    • Regulatory
    • Technology & Innovation
    • Medical Device & Healthcare
    • Pharmaceutical
    • Engineering
    • Market Research
    • Critical Alerts
    • Chemistry/Advanced Materials
  • Press Room

Click here to learn more about….

3d printing advanced materials aerospace Ask Kevin Videos biotech CFDA clinical literature evaluations commercialization strategies competitive intelligence conflict minerals Disruptive Technologies emerging markets energy EU MDR FDA food Industry 4.0 innovation Inspiring Next intellectual property intellectual property strategies IP market analysis market research medical device medical devices nerac Nerac client questions Nerac Strategist notified body audit open innovation Order 650 patenting strategies patent landscape pharmaceutical Post-Market Surveillance R&D regulatory regulatory compliance Robert Beinstein Rosemarie Szostak specialty chemicals Sustainable Development Goals technology scouting XcellR8
  • Facebook
  • Google+
  • Linkedin
  • RSS
  • Twitter
  • YouTube
  • Career Opportunities

Copyright © 2021 Nerac · One Technology Drive · Tolland, CT 06084 · 1.860.872.7000

Sign Up for the Nerac Strategist

Like what you see? Sign up here to receive the Nerac Strategist newsletter, a compilation of analyst insights on rapidly developing industry issues, compliance challenges and commercial opportunities!
  • This field is for validation purposes and should be left unchanged.