Quality First International

What is the meaning of the terms disability and handicap in the European medical device legislation?

An article published by London-based medical device regulatory consultancy Quality First International considers the terms “disability” and “handicap”, analyses and evaluates their differences in the context of available medical device legislation, identifies information asymmetry, and formulates improvements and recommendations.

London, 28 February 2018

The London-based medical device regulatory consultancy Quality First International has published a discussion paper on the meaning of the terms disability and handicap in the current European medical device legislation and recently-published Regulation. The article, published as part of the series “The Compliance Papers”, finds the terms currently to be unclear and interpretation in use confused.

“We find that the distinctions in definitions in legal sources cause indisputable divergence, which lead to confusion in interpretation and application of the scope of the legal requirements”, states Anna Novakovich, the author of the article and Junior Technical Specialist at QFI.

The article may be requested from QFI, email marija@qualityfirstint.com, reference: Novakovich, A: “When does a disability becomes a handicap?” The Compliance Papers 5 (2), 20–22, February 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.