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 the European Union, they must be certified with a CE Mark which provides evidence of compliance to this and other applicable industry standards. CE Marks list the registration number of the Notified Body who issued the CE Mark certification which is valid for three years. Technical files and Design Dossiers must be kept up to date with documentation and notification of any changes to the design, manufacture or intended use of the device. Renewal of the CE Mark is also subject to review by a Notified Body. Since the 2009 release of MedDev 2.7 Rev. 3 supplement, manufacturers have gone through the growing pains associated with implementation of a new guideline.
In addition, the European Commission is currently working on a new regulatory framework that will be released in the next year or two with sweeping changes that will affect the clinical literature evaluation process in such a way that medical device companies would benefit from having a third party provide evaluation and analysis of the clinical literature. It is estimated that these new rules will be in place as soon as 2014 and there will likely be no grace period if manufacturers are not in compliance once implemented.
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