How the new European medical device vigilance guidelines (MEDDEV 2.12-1 revision 7) will affect manufacturers
Haroon Atchia from QFI evaluates the impact of the changes introduced by the revision on manufacturers of medical devices
London, 17 May 2012
Haroon Atchia from Quality First International (QFI) has written a new article entitled “A Critical Examination of MEDDEV 2.12-1 rev 7, Guidelines on a Medical Devices Vigilance System”.
The article, which will be published in the August 2012 issue of the Journal of Medical Device Regulation, examines the differences between the still current MEDDEV 2.12-1 rev 6 (dated December 2009) and the soon-to-be-implemented MEDDEV 2.12-1 rev 7 (dated March 2012). In particular, the article evaluates the impact of such differences to manufacturers applying the vigilance guidelines.
Revision 7 of MEDDEV 2.12-1 will replace the current version on 15 June 2012.
The report is written in English.
Quality First International (QFI) is a London-based medical devices consulting company specialising in solving its clients’ regulatory, technical and compliance challenges to enable medical devices to enter the global marketplace. QFI provides regulatory advice, quality assurance and clinical trial services, with particular emphasis on the European, US, Japanese, Australian, Canadian and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
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