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 / State of the Art for Medical Devices – Applying the Requirements of MEDDEV 2.7/1 Rev. 4

State of the Art for Medical Devices – Applying the Requirements of MEDDEV 2.7/1 Rev. 4

Facebook0
Google+0
LinkedIn0
Twitter0
By Nerac Regulatory Analysts
Originally Published: July 31, 2018

The European Clinical Evaluation Guidance MEDDEV 2.7/1 Revision 4 updated many requirements for clinical evaluation of medical devices and provided detailed descriptions of what the Clinical Evaluation Report (CER) should encompass to assess and document safety and performance of a device. In particular, revision 4 clarifies the previously brief mention of state of the art.

This article explores how to establish and document state of the art in terms of CER requirements.

The article is free!

Simply fill in the form below, verify your email address
and you’ll be sent a link to download the article.
Please wait...
Loader

Related Posts

  • Notified Body Audit Trends: Be in the Know!
    73
    By Donna Mitchell-Magaldi, Nerac Analyst Originally Published: February 10, 2015 It is no surprise to anyone in the medical device industry that the European Commission is working on a new regulatory framework that will in essence take the three existing directives: Directive 90/385/EEC regarding active implantable medical devices, Directive 93/42/42 regarding medical devices, and Directive…
    Tags: clinical, art, state, regulatory, medical, device, devices, nerac, requirements
  • Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond
    52
    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, device, nerac, european, regulatory, evaluation, rev, read, meddev
  • Full Speed Ahead: Navigating the New European Medical Device Regulation
    52
    By Robert Zott, Director of Advisory Services Originally Published: July 18, 2018 The publication of the new Medical Device Regulation (MDR) 2017/745 in the European Journal, with its entry into force on May 25, 2017, marks the end of an eight-year period of controversy, and the beginning of a three-year transition to the most sweeping…
    Tags: european, device, medical, published, read, article, july, originally, devices, download_id
  • 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 Disruptive Technologies emerging markets energy EU MDR FDA food helga weires 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
  • Privacy Policy

Copyright © 2022 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.