Quality First International

EU regulation on European standardisation is insufficient to ensure independence from special interests of standardisation bodies, says British medical device expert

An article written by an international expert in US and European medical device regulations, Mr Haroon Atchia, examines Regulation (EU) No 1025/2012 on European standardisation critically, from its prime motivation to institutional elements of legitimation of standards in the context of the so-called New Approach.

London, 30 January 2018

Haroon Atchia – CEO of the London-based medical device regulatory consultancy Quality First International – has written a critical examination of Regulation (EU) No 1025/2012 on European standardisation. The article, published as part of the series “The Compliance Papers”, investigates institutional elements of the European standardisation process as they relate to the primary objective of standardisation promulgated by the Regulation. It scrutinises cruciality for economic operators – particularly manufacturers – because of legitimation of production of voluntary standards by non-governmental standardisation bodies.

“We find improper or inadequate planning, including paucity of instruction by the European Commission to her standardisation organisations, culminate in numerous standards simply promulgating lowest common denominators agreed by non-majoritarian participants on standardisation committees. The regulation espouses principles of standardisation but is insufficient to ensure independence from special interests of standardisation bodies and constitutes incoherence”, states H Atchia who is also a leading expert in compliance remediation.

The article may be requested from QFI, email marija@qualityfirstint.com, reference: Atchia, H: Examination of Regulation (EU) No 1025/2012 on European standardisation. The Compliance Papers 5 (1), 1–23, January 2018 | Quality First International.

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. QFI also specialises in various remediation and business excellence initiatives including solutions to regulatory enforcement, corporate integrity arrangements and expert witness services.