This sector-specific standard has been designed to help manufacturers, developers and technical assessors design, develop and evaluate medical device apps

For medical device manufacturers who want to understand the requirements of the UK’s new MHRA MORE platform for submissions of device related incidents: New WEBINAR presented by Haroon Atchia is available

This sector-specific standard helps manufacturers understand and ensure sustainable environmental realisation by considering recognised system boundaries, total medical device life-cycle, and environmental risk-thinking through a dedicated, stochastic management system. London, 1 August 2022 London-based medical device regulatory consultancy Quality First International has published medical device standard QFIS 003:2022 Medical device environmental (waste) management system specification . It is intended for use as a sector-specific management system and to be used in conjunction with relevant trusted standards and good practices. The standard is applicable to all types of medical devices, support services, externally-provided raw materials, intermediate products and components, constituents, processes and utilities applied to produce, supply, sustain and ultimately dispose of medical devices. “Sustainability may not be achieved without both full characterisation of a medical device to its environmental fundamentals and its imprint throughout its complete life-cycle, says Haroon Atchia, CEO and Technical Director of QFI. This is crucial in all environmental compartments relevant to a medical device, defining its planetary or system boundaries and safe operating space, intertwined with its basic environmental performance and impact. Standard QFIS 003:2022 is the first and only standard on this specific subject matter to date. Atchia further explains that “only QFI can assist medical device manufacturers with the know-how and practical resources to implement concepts and radical solutions described by our standard. Also, only QFI’s environmental technical specialist team can conduct comprehensive assessments to the standard. We offer these services as part of our business programme to our members but can also do so on an individual project basis.” The standard is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 175.00 GBP. The price for QFI Medical Device Environmental Management Programme members is 139.00 GBP. About Quality First International (QFI) QFI is a London-based medical device 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. 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. For further information please contact: Tel: +44 (0)208 221 2361, Email: enquiries@qualityfirstint.com , Website: https://qualityfirstint.com .

The Department for Business and Trade (DBT) has announced its intention to indefinitely extend the recognition of CE marking for certain industry sectors. This decision means that UKCA marking will no longer be mandatory from the end of December 2024 for businesses included in the 18 regulations that fall under the Department for Business and Trade (DBT).

The Medical Devices Regulations 2002 currently specify that the acceptance of CE marked medical devices on the Great Britain market will end on 30 June 2023. However, on 9 June 2023, the UK government put in place legislation to extend the acceptance of certain CE marked medical devices on the Great Britain market in response to similar changes made in the European Union.