By Robert Zott
Originally Published: February 7, 2018
The European Union is undergoing the most sweeping regulatory changes in its history with regard to medical devices. The sheer number and scope of the changes have left manufacturers stunned and scrambling for pathways to compliance under MEDDEV Clinical Evaluation Guidance 2.7/1 Revision 4 or in anticipation of the new Medical Device Regulation (MDR). As a result, nonconformity reigns and the creation of Clinical Evaluation Reports (CERs)—the key documents used to meet the current Medical Device Directive (MDD)—is fraught with misguided approaches that might appear to meet the regulations on paper, but bear little resemblance to the real-world needs of patients.
This article explores potential pitfalls now faced by device manufacturers regarding CERs and offers guidance on how to navigate them with success. Learn more here!
Get Our Free Article
Simply fill in the form below, verify your email address
and you’ll be sent a link to download our free article.
- 61By 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…
- 59When it comes to the new European Medical Device Regulation (MDR), it’s critical to know where you stand. Take a look at the MDR timeline here.
- Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond51By 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…