DEADLINE FOR RE-REGISTRATION OF MEDICAL DEVICES AND IVDs IN THE UK IS 31 MAY 2009
London, 17 April 2009
The European Union (EU) has revised the various Medical Device Directives regulating how products are approved for sale in the 27 EU Member States. Quality First International (QFI), the London-based medical devices consultancy, is alerting all device manufacturers to the important implications for marketed devices.
Specifically, implementation of Amending Directive 2007/47/EC in the UK now means that data held by the Medicines and Healthcare products Regulatory Agency (MHRA) will be available publicly from 21 March 2010. Consequently, for instance, all EU Authorised Representatives (EUARs) are now required to re-submit information on manufacturers and products they have registered with the MHRA, including Schedules of Products, no later than 31 May 2009.
QFI has also published a free white paper on Amending Directive 2007/47/EC on the company website at www.qualityfirstint.com/freewhitepaper.htm.
"At stake is maintaining or increasing share in the European medical devices market", says Haroon Atchia, CEO and Technical Director of QFI. "Failure to comply with the new requirements will result in products no longer being legally available on the market and consequently serious disruptions to manufacturers' sales activities".
About Quality First International (QFI)
Quality First International (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 and Chinese marketplaces. All submissions made by QFI have fulfilled the compliance requirements first time round, consistently. QFI clients range from start-up companies to multinational organisations, primarily developing a broad range of cutting-edge, minimally invasive and cardiovascular products and implants.
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