Effective: Published June 27th, entering into force 20 days later Amends: Commission Implementing Regulation (EU) 2025/1234 Purpose: To broaden the scope of devices eligible to provide IFUs in electronic form instead of paper. The EU now al…
MedTech Europe has taken another significant step in its push for digital healthcare. Following its 2025 position paper calling for eIFU acceptance for selected lay-use medical devices, the organisation has now published a new booklet — “Gr…
MedTech Europe has taken another significant step in its push for digital healthcare, publishing new guidance on eIFU for near-patient tests following its position paper on lay-use devices. Dir. Authorised Representative Services & Manager
Learn why system validation is the foundation of eIFU compliance and how to ensure your electronic Instructions for Use platform meets regulatory requirements under EU MDR and IVDR. Electronic Instructions for Use (eIFU) systems must be val…
Post-market surveillance has become more critical than ever. Learn how eIFU can revolutionize PMS in the IVD and MD industry. Content & Communications Manager In today's rapidly evolving healthcare technology landscape, efficient post-marke…
In today’s rapidly evolving landscape of healthcare technology, the need for efficient post-market surveillance (PMS) in the In Vitro Diagnostic (IVD) and Medical Device (MD) industry has become more critical than ever. With advancements in…
Regulatory requirements, integration and validation are at the core of IFUcare's design. In-house regulatory, quality, support & development specialists End-to-end validation built into the platform No regulatory surprises or hiccups Truste…
A standalone eIFU solution, backed by regulatory experts in IVD and Medical Devices IFUcare was founded in 2008 by regulatory experts specializing in Quality Systems and Regulatory Affairs for the IVD and medical device industries. The deve…
Everything you need for compliant eIFU distribution, built by regulatory experts Our platform is EU/FDA regulation compliant and can be configured to suit your needs. Distinct groups of documents can be made available for different countrie…
Discover why leading medical device manufacturers choose IFUcare for their eIFU needs IFUcare enables medical device (MD) and in vitro diagnostic (IVD) manufacturers to leave paper instructions for use (IFU) out of product packaging and mak…
Expert articles, guides, and whitepapers on eIFU compliance, regulatory requirements, and digital transformation in medical devices. Professional-use medical devices and IVDs(subject to applicable regulatory requirements) Learn why system v…
A practical whitepaper on the software requirements for a compliant eIFU platform Covering Medical Devices and In Vitro Diagnostics under EU MDR, IVDR, and global expectations. This whitepaper gives you a practical overview to help you impl…