Deadline for Re-Registration of Medical Devices and IVDs in the UK is 31 May 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.
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”.
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.
For further information please contact:
Marija Capek, PR and Press Officer
Tel: +49 (0)621 166 2326
+49 (0)621 166 2326