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e-IFU requirements translated for implantable medical devices
After the European Commission published the Commission Implementing Regulation (EU) 2021/2226 on 14 December 2021 – laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council with regards to electronic instructions for use of medical devices, replacing the Commission Regulation (EU) No 207/2012 of 9 March 2012 on electronic instructions for use of medical devices, a new era began.
IFUcare: its history, evolution of eIFU regulations and the road ahead
IFUcare is Europe’s leading companies when it comes to providing firms with IFU and eIFU support. The company’s growth since 2007 provides an insight into how the IVD and MD world is evolving
eIFUs: why electronic instructions are just part of the package
Many manufacturers have already started to enjoy the benefits of eIFU for Medical Device (MD) and In Vitro Diagnostic (IVD) products. But the benefits extend far beyond electronic instructions – offering wide-ranging opportunities in other essential business services for both existing users and those yet to take the plunge
A guide to the eIFU transition
Administrative and logistical hurdles around the switch from paper to eIFU can be daunting for manufacturers. Choosing the right partner helps tackle the challenges and maximise the rewards