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 regulatory changes since the founding of the European Union.
Since this new Medical Device Regulation has been published in its final form, the three-year transition clock has been set in motion, and the risk of many devices leaving the European market looms large in the minds of manufacturers, regulators and auditing bodies, alike.
This article explores the impact of these significant changes. Read more here!
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.
- The New Post-Market Surveillance Regulations for Europe, Part 2: Serious Incidents Get A Serious Overhaul.78By Robert Zott, Director of Advisory Services Development Originally published November 13, 2018 There is now 1 year, 6 months and 20 days until the application date upon which the new European Medical Device Regulation (MDR) goes into effect. For those charged with the task of upgrading systems for MDR compliance, that’s 567 days or…
- 75By 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…
- Clinical Literature Evaluations via an Objective Third Party Reviewer: Maintaining Compliance with the EU Medical Directives and Beyond61By 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…