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 UK Competent Authority (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 UK 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, they 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.