Does persistence with EN ISO 13485: 2012 undermine European medical device legislation?
A new paper written by Haroon Atchia questions the adequacy of EN ISO 13485: 2012 and raises the question of whether the standard is more focused on quality assurance registration schemes than meeting current European regulations.
London, 3 September 2014
Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written an article on the adequacy of EN ISO 13485: 2012 with regard to the quality system requirements of the European Directives on medical devices.
The paper entitled "A critical examination of the discordance between EN ISO 13485: 2012 and the quality system requirements of the European Directives on medical devices" examines in detail the text of the standard and its concordance with the European Directives, discovering quite a few contradictions and asymmetries.
"These conflicts with European legislation continue to undermine compliance and confidence in the CE marking system for medical devices. Furthermore, they condone and encourage violation of the legislation by implying that registration of an EN ISO 13485 QMS is sufficient to comply with the relevant regulations. Consequently, non-compliant medical devices reach the market under the guise of a QMS certificate awarded against EN ISO 13485, with any concomitant certificate awarded against, for example, Annex II a simple matter of course", says H Atchia.
The English language article of 17 pages has been published in electronic format (PDF) by Global Regulatory Press at
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About Quality First International (QFI)
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, Mexican and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI’s 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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