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E-IFU Portal
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System availability & contingency procedure

Published in accordance with Art 4.2(h) and Art 7(2c) of Regulation (EU) 2021/2226.

Service level

The eIFU portal is hosted on a globally-distributed edge network with a target availability of 99.9% per calendar month. All historical versions are retained for the periods set by Art 5(9)(10) (10 years after last placement on the market for non-implantable devices with an expiry date, plus 2 years past the last expiry date; 15 years for implantable devices and devices without a defined expiry date).

If the website is temporarily unavailable

  1. Try again in a few minutes — most outages are short-lived.
  2. Contact the manufacturer's customer service to request the Instructions for Use by email (delivered as a PDF readable with freely available software).
  3. Request a printed copy free of charge via your sales representative or on this site once available — see the catalog and open the product page, then "Request paper copy". The paper copy will be delivered within 7 calendar days (Art 5(3)).

Stability of links

URLs of the form /p/<product>/<language> are guaranteed stable for the full retention period. QR codes printed on packaging or paper leaflets point to these stable URLs (Art 7(2e)).

Security

Files are served over HTTPS only. Document integrity is monitored via SHA-256 hashes recorded at synchronisation time; all administrative actions are recorded in a tamper-evident audit log (Art 4.2(e), 7(2b)).