Quality First International

Harmful and unregulated: How is medical device waste being handled under EU regulations?

An article written by London-based medical device regulatory consultancy Quality First International analyses and evaluates the available regulations, systems, standards and guidance for medical device environmental waste produced during the manufacturing stage and throughout the supply chain.

London, 8 May 2018

The London-based medical device regulatory consultancy Quality First International has written an article on the nature and extent of medical device environmental waste produced during the manufacturing stage and throughout the supply chain. The article has been published in the May issue of the Journal of Medical Device Regulation. The author analyses and evaluates the available regulations, systems, standards and guidance; identifies information asymmetry and formulates improvements and recommendations. The article also evaluates if ‘environment’ in the context of medical devices is defined adequately as a concept.

“We find that environmental issues – particularly medical device environmental waste issues – are largely absent from the European Directives and Regulations used by the medical device sector”, states Anna Novakovich, the author of the article and Junior Technical Specialist at QFI. ”However, without a specific legislation, it is impossible to understand the direct and indirect costs and impact of devices on the environment”.

The article may be purchased from Global Regulatory Press at the special price of £89 (plus VAT as applicable), email: sales@globalregulatorypress.com to order a copy.

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.