Field-tested thinking from the team building YDNTFY.https://ydntfy.com/en-GBhttps://ydntfy.com/en/blog/eudamed-eifu-url-field/https://ydntfy.com/en/blog/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.Thu, 03 Sep 2026 00:00:00 GMTKoen StyneneIFU RegulationMDRIVDRhttps://ydntfy.com/en/blog/ai-act-instructions-for-use-medical-devices/https://ydntfy.com/en/blog/ai-act-instructions-for-use-medical-devices/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.Thu, 27 Aug 2026 00:00:00 GMTKoen StynenAI ActMDReIFU Regulationhttps://ydntfy.com/en/blog/authorised-representative-eifu-responsibility/https://ydntfy.com/en/blog/authorised-representative-eifu-responsibility/Regulation (EU) 2021/2226 assigns every eIFU duty to the manufacturer. What that leaves the authorised representative to verify, hold and produce on request.Fri, 21 Aug 2026 00:00:00 GMTKoen StynenMDReIFU RegulationIVDRhttps://ydntfy.com/en/blog/eifu-open-to-every-professional-use-device/https://ydntfy.com/en/blog/eifu-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.Thu, 13 Aug 2026 00:00:00 GMTKoen StyneneIFU RegulationMDRhttps://ydntfy.com/en/blog/ppwr-applies-today-medical-device-packaging-leaflet/https://ydntfy.com/en/blog/ppwr-applies-today-medical-device-packaging-leaflet/The EU Packaging Regulation applies from today. Which derogations are real, and why February 2028 matters more than 2030.Wed, 12 Aug 2026 00:00:00 GMTKoen StynenPPWRMDR