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.

The European Commission has published an amendment to the Medical Device Regulation (MDR) in the Official Journal. One of the amendment’s main features is the extension of the MDR transition periods until 31 December 2027 or 31 December 2028, depending on the device class.

London, 21 December 2022 London-based medical device regulatory consultancy Quality First International has published a new book entitled Introduction to fundamental and applied quality system for medical devices . This book aims to identify the fundamentals of a quality system and provide a science-based construct that will hopefully produce a greater understanding and application of quality system standards. “Despite numerous publications about quality, quality systems and quality management systems, the respective meanings of these terms are less clear than one might perhaps initially think.”, says Haroon Atchia, author of the book and CEO and Technical Director of QFI. “Even the meaning of system promulgated by ISO is unclear and certainly incomplete. There is no legal definition of quality in the context of a consumer product, including a medical device, contrary to popular myth and extensive use of the word throughout medical device regulations and related texts. Contemporary medical device manufacture and service organisations therefore routinely misinterpret quality as a documented management system, somehow losing sight of true definitions.” The ubiquity and importance of the use of quality systems and quality management system standards obligates the need for an improved definition of quality as a metric along with a clarification of why each quality system element is an essential or characteristic component of a quality system. The book is available from QFI upon request, please contact enquiries@qualityfirstint.com . Price: 130.00 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 .

London-based medical device regulatory consultancy Quality First International (QFI) reminds medical device manufacturers of the approaching end of the grace period for transitioning from compliance under the European Directives and Regulations for medical devices and IVDs London, 11 May 2022 With the end of the transition period set for 30 June 2023, QFI encourages all manufacturers to apply to UK Approved Bodies as soon as possible to avoid discontinuation or failure to place products on the Great Britain market. The Enforcement Agency (MHRA) will no longer accept medical device compliance under Council Directives 93/42/EEC, 90/385/EEC and 98/79/EC, nor Regulations (EU) 2017/745 / 2017/746 after 30 June 2023. Further, all manufacturers intending to place medical devices on the UK market must comply with the Medical Devices Regulations 2002 No. 618 (as amended) and apply a UKCA mark to their products. “The new requirements apply to devices of all classes. We anticipate long conformity assessment processes with UK Approved Bodies”, says Haroon Atchia, CEO and Technical Director at QFI. “Furthermore, the UK MHRA will only accept registration of devices from manufacturers where the manufacturer is based in the UK. If the manufacturer is based outside the UK, he must appoint a UK Responsible Person.” 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. The company also acts as a UK Responsible Person for manufacturers located outside of the UK. 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 London-based medical device regulatory consultancy Quality First International (QFI) has launched a new programme intended to assist medical device manufacturers in the development of environment-friendly, eco-designed and green medical devices. “We think it is high time that sustainability and eco-friendliness become topics of discussion in the industry”, says QFI’s CEO and Technical Director Haroon Atchia. “State-of-the-art technology and a value-oriented business culture should go hand in hand nowadays. Our programme can assist value-driven medical device manufacturers to achieve environment-friendly medical devices and to gain leadership through continual improvement of business processes towards environmental sustainability. Our ideas and initiative are fundamental, visionary and innovative, not simply management system-based. Our goal is a certified environment-friendly medical device sector.”