Manufacturers are advised to establish formal procedures to determine if an accessory or other component of a medical-electrical equipment is ‘applied’
An article published by London-based medical device regulatory expert Haroon Atchia explores the concept of an ‘applied part’, as described and defined by the standard on medical-electrical equipment safety, and not by legislation or regulation.
London, 8 March 2018
The international medical device regulatory expert Mr Haroon Atchia has published an article on the theoretical, practical and regulatory implications of the concept of an ‘applied part’ within the meaning of EN 60601-1, and in the context of consumables supplied as accessories for use with a particular medical-electrical equipment. The article looks at how particular standards covering certain types of medical-electrical equipment may elaborate conditions under which an applied part must be tested. The article has been published as part of the series “The Compliance Papers”.
“This research indicates critical scientific debate about the concept of applied parts is overdue, and a programme to improve uniformity in how such parts are dealt with in particular standards might be necessary”, states the author of the article who is also a microbiologist, a cardiovascular, blood contact & non-active implantable device specialist, a plastics technologist and an Expert Witness.
The article may be requested from QFI, email email@example.com, reference: Atchia, H: On the trail of an applied part. The Compliance Papers 5 (3), 1–18, March 2018 | Quality First International. Price: £35 plus VAT as applicable.
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.