Medical device literature reviews for EU CERs present a challenge to many manufacturers. The literature review component of your CER will undergo robust scrutiny by the Notified Bodies. This article outlines an MDR compliant, systematic literature review process. Access the article here. The article is free!Simply fill in the form below, verify your email address |
Related Posts
- 66By 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…
- 62By 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…
- 58The claims a manufacturer chooses to make about its medical device are an important aspect of the product and are closely tied to its safe use and optimal performance. Device claims are a part of the advertising and promotion of a product which, in the European Union, are regulated by MDR 201/745, along with several EU…