A device labelled STERILE in the Union is expected to meet the requirement of EN 556-1, a theoretical probability of no more than one viable micro-organism in one million devices. A file built on a less demanding assurance level is the single most expensive gap to close, because it is a process question, not a paperwork question.
Sterile devices
Sterile devices: the European evidence a US sterilization file often lacks
Sterilization is where a well-built American file most often runs short in Europe, and the reason is rarely the process itself. It is the surrounding evidence: what the sterility claim is based on, what residues remain, how long the barrier holds, and who has to certify it.
Class I sterile is not self-certification
Article 52(7) MDR, on class I devices placed on the market in sterile condition, with a measuring function or as reusable surgical instruments:
the involvement of the notified body in those procedures shall be limited: (a) in the case of devices placed on the market in sterile condition, to the aspects relating to establishing, securing and maintaining sterile conditions
The manufacturer still draws up the declaration of conformity itself and still compiles the technical documentation under Annexes II and III. What it cannot do is place the device on the market without a notified body certificate covering sterility. Companies used to the FDA classification, where a class I device is usually exempt, plan their timeline without that certificate and lose a quarter.
The four evidence sets a European file is built on
Harmonised standards give presumption of conformity where they are cited in the Official Journal, so the edition matters as much as the standard number.
Ethylene oxide to ISO 11135, radiation to ISO 11137, moist heat to ISO 17665, each with the adoption and any amendment cited for the EU.
For ethylene oxide, residual limits for EO and ethylene chlorohydrin under ISO 10993-7, alongside the biological evaluation under ISO 10993-1 with chemical characterisation where the contact category calls for it.
Sterile barrier system design and validation to ISO 11607-1 and ISO 11607-2, with real-time and accelerated ageing supporting the shelf life that appears on the label.
Shelf life is a labelling obligation, not a marketing choice
US manufacturers frequently sell sterile devices without a validated expiry date, because the domestic route did not force the question. In Europe the label of a sterile device has to carry the information set out in Annex I Chapter III, and a date the manufacturer cannot support with ageing data will not survive a technical documentation review.
The practical consequence is sequencing. Ageing studies take calendar time that no consultant can compress, so the shelf life question belongs at the start of an EU project, before the notified body application, not after the first deficiency letter.
Ethylene oxide carries a second regulatory conversation
Beyond device law, ethylene oxide is a substance under chemicals and biocides legislation, and the MDCG has issued guidance addressing its regulatory status for device sterilization. For a manufacturer that contracts out sterilization, the point to settle early is where the process is performed, under whose authorisations, and what that means for supply into the Union.
This is also where contract sterilizer agreements get read. A notified body will look at how the manufacturer controls a supplier that holds the process knowledge, and a one-page service agreement is not that control.
Questions about sterile product lines
Our device is sterilized by our contract sterilizer under their validated cycle. Is that enough?
Only if the validation covers your product family, load configuration and packaging, and only if you hold the data. A cycle validated for somebody else does not transfer with the invoice.
Can we keep our US label and add a translation?
No. The European label is built from Annex I Chapter III, uses the symbols of the harmonised symbol standard, carries the UDI, the CE marking with the notified body number where applicable, and the details of the manufacturer, the authorised representative and the importer.
We use a 10 to the minus three assurance level for a non-implant device. Does the EU accept it?
Not for a device you label as sterile. That is why the assurance level question is asked in the first review, before anything else in the sterilization file.
Official basis checked on 15 August 2026
The MDR provisions cited on this page were checked against the official EUR-Lex text.
Regulation (EU) 2017/745 (MDR) in EUR-Lex →
Plan the EU route
Map the work before committing to a certification timeline.
Use the US-to-EU hub to separate reusable evidence from European work, or review the wider service scope for manufacturers established outside the Union.