Note su eIFU, conformità e passaggio all’elettronico.
Riflessioni testate sul campo dal team che costruisce YDNTFY.
eIFU for lay users: why we support opening it, safety first
Paper is still mandatory wherever lay use is foreseeable. Why the line sits there, why we support the industry proposal to move it, and the safety test it must pass.
Which address goes in the EUDAMED eIFU URL field?
The MDR marks the EUDAMED URL field optional. If your IFU is electronic, Article 7(3) of Regulation 2021/2226 makes it mandatory and names the address.
What the EU AI Act adds to your device's instructions for use
Article 13 of the EU AI Act sets its own list of IFU contents for high-risk AI. For an MDR or IVDR device it lands on top of Annex I, from 2 August 2028.
Who owns the eIFU: you or your authorised representative?
Regulation (EU) 2021/2226 assigns every eIFU duty to the manufacturer. What that leaves the authorised representative to verify, hold and produce on request.
eIFU is now open to every professional-use device
In June 2025 the EU widened electronic instructions for use from three device types to all professional use. What changed, and what quietly got easier.
PPWR applies today: what it asks of medical device packaging
The EU Packaging Regulation applies from today. Which derogations are real, and why February 2028 matters more than 2030.